Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer.

PURPOSE: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.

Further Study Information

OBJECTIVES:

Primary

• To assure that neoadjuvant oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX) followed by selective use of combined modality therapy with fluorouracil (5FUCMT) group (Group 1) maintains the current high rate of pelvic R0 resection and is consistent with non-inferiority for time to local recurrence (TLR). (Phase II)

• To compare neoadjuvant FOLFOX followed by Selective use of 5FUCMT (Group 1) to standard 5FUCMT (Group 2) with respect to the proportion of patients who achieve a pathologic complete response (pCR) at the time of surgical resection. (Phase III)

• To compare bowel function in patients randomized to the neoadjuvant FOLFOX followed by selective use of 5FUCMT vs standard 5FUCMT at approximately 1 and 2 years postoperatively.

• To evaluate the feasibility of implementing the PRO-CTCAE in an NCI-sponsored treatment trial.

• To evaluate the feasibility of implementing the PRO-CTCAE at Alliance sites.

• To evaluate the feasibility of patients self-reporting symptoms during treatment by using the PRO-CTCAE.

• To prospectively use Molecular Inversion Probe (MIP) array technology and MALDI-TOF mass spectrometry-based genotyping to identify copy number aberrations and somatic mutations that mediate tumor formation using formalin-fixed, paraffin-embedded (FFPE) tumor tissue from patients participating in the current study.

• To determine whether germline genetic variants in candidate genes of interest are associated with response and/or toxicity to platinum and 5FU-based chemotherapy.

Secondary

• To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard group 5FUCMT (Group 2) with respect to the proportion of patients who achieve a pCR at the time of surgical resection.

• To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard 5FUCMT (Group 2) with respect to overall survival.

• To evaluate and compare the adverse event profile and surgery complications between the two groups.

• To estimate the proportion of patients in the selective group (Group 1) who receive pre-operative 5FUCMT, post-operative 5FUCMT, and either pre- or post-operative 5FUCMT.

• To compare sexual function separately within men and within women between groups at approximately 1 and 2 years post-operatively.

• To compare bladder function between groups at approximately 1 and 2 years post-operatively.

• To compare health-related quality of life between groups at 1 and 2 years post-operatively.

• To assess the correlation between bladder, bowel, and sexual function and quality of life. (Exploratory)

• To investigate factors associated with bladder, bowel, and sexual dysfunction. (Exploratory)

• To compare bladder and bowel function over time between genders. (Exploratory)

• To perform subgroup analyses based on other sociodemographic factors. (Exploratory)

• To evaluate and compare patients' self-reported symptom burden during treatment between groups using the PRO-CTCAE system.

• To evaluate whether exposure to patient-reported symptoms influences CTCAE symptom reporting by research staff. (Exploratory)

• To correlate the MIP array copy number and mutational data from patients with locally advanced rectal cancer with clinical outcome in each treatment cohort (the clinical outcomes include pathologic complete response, time to recurrence, time to pelvic recurrence, and overall survival).

• To identify immune markers for response to neoadjuvant chemotherapy or chemoradiation using very well-established, validated immunologic assays.

• To investigate the ability of neoadjuvant FOLFOX or chemoradiation to augment anti-tumor immunity against rectal cancer.

• To identify novel immune targets in rectal cancer.

• To determine whether germline genetic variants in candidate genes of interest are associated with response and/or toxicity to radiation therapy.

• To assess whether genetic-risk variants identified in genome-wide association studies of colorectal cancer susceptibility are associated with rectal cancer clinical outcome and response to therapy.

OUTLINE: This is a multicenter, phase II study followed by a phase III study. Patients are stratified according to ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

• Group 1 (FOLFOX): Patients receive neoadjuvant chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with at least 20% of tumor regression undergo low-anterior resection (LAR) with total mesorectal excision (TME). Patients with less than 20% of tumor regression undergo chemoradiation as in group 1 before proceeding to LAR with TME.

• Group 2 (5FUCMT): Patients receive fluorouracil IV continuously 7 days a week for 5.5 weeks or capecitabine orally (PO) twice daily (BID) 5 days a week for 5.5 weeks. Patients also undergo 3-dimensional conformal or intensity-modulated radiation therapy 5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME.

Patients in both groups may receive adjuvant chemotherapy comprising FOLFOX and/or 5FUCMT.

Patients undergo blood sample collection at baseline and periodically during study for genotyping and immunologic studies. Paraffin-embedded tissue samples from primary tumor are also collected for aberration and somatic mutation studies by molecular inversion probe (MIP) array and mass spectrometry-based genotyping.

Patients complete the Bowel Function Index, the Prostate Health-Related Quality-of-Life (QOL) and the International Prostate Symptom Score (IPSS) questionnaires, the EuroQOL5D-5L (EQ5D) questionnaire, and the International Index of Erectile Function (IIEF) or Female Sexual Function Index (FSFI) questionnaire at baseline, and periodically during study.

After completion of study treatment, patient are followed up for up to 8 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of rectal adenocarcinoma

• Radiologically measurable or clinically evaluable disease

• For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined-modality, neoadjuvant chemoradiation followed by curative-intent surgical resection

• Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon

• No patient for whom primary surgeon indicates need for abdominoperineal (APR) at baseline

• Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)

• Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT scan of the chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS)

• Clinical stage N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm

• No clinical T4 tumors

• Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal verge, inclusive

• No evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan

• No tumor causing symptomatic bowel obstruction

PATIENT CHARACTERISTICS:

• ECOG performance status 0, 1, or 2

• Absolute neutrophil count (ANC) ≥ 1,500/mm³

• Platelets ≥ 100,000/mm³

• Hemoglobin > 8.0 g/dL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 3 times ULN

• Creatinine ≤ 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Patient of child-bearing potential is willing to employ adequate contraception

• Willing to return to enrolling medical site for all study assessments

• No other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix

• No co-morbid illnesses or other concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)

• No prior pelvic radiation

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

Deborah Schrag

Principal Investigator

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Robert McWilliams	Ph: 507-538-7623
California
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Samuel C. Oommen	Ph: 925-674-2580
	LA Jolla
	Rebecca and John Moores UCSD Cancer Center
		Kelly A Shimabukuro	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
	Mountain View
	Palo Alto Medical Foundation
		Peter P. Yu	Ph: 650-934-7000
	Palo Alto
	Palo Alto Medical Foundation
		David S Leibowitz	Ph: 650-853-2906
			Email: waldorj@pamf.org
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Alan Paul Venook	Ph: 877-827-3222
	Stanford
	Stanford Cancer Center
		George A Fisher
			Email: ccto-office@stanford.edu
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Samuel C. Oommen	Ph: 925-674-2580
Colorado
	Aurora
	Medical Center of Aurora - South Campus
		Eduardo R. Pajon	Ph: 888-785-6789
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Littleton
	Littleton Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Brian J Byrne	Ph: 860-224-5660
	Norwalk
	Norwalk Hospital
		Richard C. Frank	Ph: 203-852-2996
			Email: jennifer.long@norwalkhealth.org
Delaware
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Stephen Scott Grubbs	Ph: 302-733-6227
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		John L. Marshall	Ph: 202-444-0381
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Gainesville
	University of Florida Shands Cancer Center
		Thomas J George	Ph: 352-273-8675
			Email: trials@cancer.ufl.edu
	Jacksonville
	Mayo Clinic - Jacksonville
		Robert McWilliams	Ph: 507-538-7623
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
Georgia
	Atlanta
	Emory Crawford Long Hospital
		Patrick S Sullivan	Ph: 404-778-1868
	Winship Cancer Institute of Emory University
		Patrick S Sullivan	Ph: 404-778-1868
	Columbus
	John B. Amos Cancer Center
		William E Taylor	Ph: 706-660-6404
	Decatur
	Veterans Affairs Medical Center - Atlanta (Decatur)
		Wayne B. Harris	Ph: 404-778-1868
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Harvey C. Lebos	Ph: 912-350-8568
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
Illinois
	Chicago
	John H. Stroger, Jr. Hospital of Cook County
		Michael R Mullane	Ph: 312-864-6000
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Amy L Halverson	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		Blase N Polite	Ph: 773-834-7424
	Evanston
	CCOP - Evanston
		Marc A Singer	Ph: 847-570-1381
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Amy L Halverson	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Amy L Halverson	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Moline
	Garneau, Stewart C MD (UIA Investigator)
		Costas L. Constantinou	Ph: 319-363-2690
	Porubcin, Michael MD (UIA Investigator)
		Costas L. Constantinou	Ph: 319-363-2690
	Spector, David MD (UIA Investigator)
		Costas L. Constantinou	Ph: 319-363-2690
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas L. Constantinou	Ph: 319-363-2690
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Amy L Halverson	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Rockford
	Swedish-American Regional Cancer Center
		Harvey Eric Einhorn	Ph: 815-489-4413
	Skokie
	Hematology Oncology Associates - Skokie
		Amy L Halverson	Ph: 312-695-1301
			Email: cancer@northwestern.edu
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Rao Nattam	Ph: 260-484-8830
			Email: ledgar@fwmoh.com
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Patrick J. Loehrer	Ph: 317-274-2552
	St. Francis Hospital Cancer Care Services
		Howard M. Gross	Ph: 765-983-3000
	William N. Wishard Memorial Hospital
		Patrick J. Loehrer	Ph: 317-274-2552
	Richmond
	Reid Hospital & Health Care Services
		Howard M. Gross	Ph: 765-983-3000
Iowa
	Bettendorf
	Constantinou, Costas L MD (UIA Investigator)
		Costas L. Constantinou	Ph: 319-363-2690
	Clive
	Medical Oncology and Hematology Associates-West Des Moines
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Mercy Cancer Center - West Lakes
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	West Des Moines
	Methodist West Hospital
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker R. Dakhil	Ph: 316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker R. Dakhil	Ph: 316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker R. Dakhil	Ph: 316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker R. Dakhil	Ph: 316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker R. Dakhil	Ph: 316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker R. Dakhil	Ph: 316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker R. Dakhil	Ph: 316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker R. Dakhil	Ph: 316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker R. Dakhil	Ph: 316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker R. Dakhil	Ph: 316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker R. Dakhil	Ph: 316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker R. Dakhil	Ph: 316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker R. Dakhil	Ph: 316-262-4467
	Wichita
	Associates in Women's Health, PA - North Hillside
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	CCOP - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Wesley Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker R. Dakhil	Ph: 316-262-4467
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Jyotsna Fuloria	Ph: 888-562-4763
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Thomas Henry Openshaw	Ph: 207-973-4274
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Navesh K Sharma	Ph: 800-888-8823
	Salisbury
	Peninsula Regional Medical Center
		Paul E Zorsky	Ph: 410-543-7017
			Email: sandra.heineken@peninsula.org
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Andrea J Bullock	Ph: 617-667-9925
	Dana-Farber/Brigham and Women's Cancer Center
		Deborah Schrag	Ph: 866-790-4500
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Deborah Schrag	Ph: 866-790-4500
	Massachusetts General Hospital
		Deborah Schrag	Ph: 866-790-4500
	Burlington
	Lahey Clinic Medical Center - Burlington
		Keith Ellis Stuart	Ph: 781-744-8027
	Milford
	Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
		Deborah Schrag	Ph: 866-790-4500
	Pittsfield
	Berkshire Hematology Oncology, PC
		Harvey Zimbler	Ph: 413-496-8205
			Email: Gloria.Gero@berkshirehemonc.com
	South Weymouth
	Dana-Farber/Brigham and Women's Cancer Center at South Shore
		Deborah Schrag	Ph: 866-790-4500
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Christopher M Reynolds	Ph: 734-712-3456
	Saint Joseph Mercy Cancer Center
		Christopher M Reynolds	Ph: 734-712-3456
	University of Michigan Comprehensive Cancer Center
		Marwan Fakih	Ph: 800-865-1125
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Detroit
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Flint
	Genesys Hurley Cancer Institute
		Christopher M Reynolds	Ph: 734-712-3456
	Hurley Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Jackson
	Gayle M. Jacob Cancer Center at Allegiance Health
		Christopher M Reynolds	Ph: 734-712-3456
	Kalamazoo
	Borgess Medical Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Bronson Methodist Hospital
		Raymond Sterling Lord	Ph: 269-373-7458
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Christopher M Reynolds	Ph: 734-712-3456
	Livonia
	St. Mary Mercy Hospital
		Christopher M Reynolds	Ph: 734-712-3456
	Pontiac
	St. Joseph Mercy Oakland
		Christopher M Reynolds	Ph: 734-712-3456
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Christopher M Reynolds	Ph: 734-712-3456
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Christopher M Reynolds	Ph: 734-712-3456
	Warren
	St. John Macomb Hospital
		Christopher M Reynolds	Ph: 734-712-3456
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston D. Steen	Ph: 701-234-6161
	Burnsville
	Fairview Ridges Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Edina
	Fairview Southdale Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Rochester
	Mayo Clinic Cancer Center
		Robert McWilliams	Ph: 507-538-7623
	Saint Cloud
	CentraCare Clinic - Women and Children
		Donald J Jurgens	Ph: 877-229-4907
			Email: coborncancercenter@centracare.com
	Coborn Cancer Center
		Donald J Jurgens	Ph: 877-229-4907
			Email: coborncancercenter@centracare.com
	Saint Louis Park
	CCOP - Metro-Minnesota
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Daniel M Anderson	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany G. Sleckman	Ph: 913-948-5588
	Southeast Cancer Center
		Alan Philip Lyss	Ph: 800-392-0936
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Zihao Wu	Ph: 573-882-7440
	Jefferson City
	Goldschmidt Cancer Center
		Alan Philip Lyss	Ph: 800-392-0936
	Rolla
	Mercy Clinic Cancer and Hematology - Rolla
		Robert L Carolla	Ph: 417-269-4520
	Saint Louis
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Missouri Baptist Cancer Center
		Alan Philip Lyss	Ph: 800-392-0936
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Benjamin R Tan	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
	Springfield
	Cancer Research for the Ozarks
		Robert L Carolla	Ph: 417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert L Carolla	Ph: 417-269-4520
	St. John's Regional Health Center
		Robert L Carolla	Ph: 417-269-4520
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
	CCOP - Montana Cancer Consortium
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Thomas Marchello	Ph: 800-648-6274
	St. Vincent Healthcare Cancer Care Services
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Butte
	St. James Healthcare Cancer Care
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Great Falls
	Benefis Sletten Cancer Institute
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Great Falls Clinic - Main Facility
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Helena
	St. Peter's Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Kalispell
	Kalispell Regional Medical Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Montana Cancer Specialists at Montana Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Stefan D Holubar	Ph: 800-639-6918
			Email: cancer.research.nurse@dartmouth.edu
New Jersey
	Basking Ridge
	Memorial Sloan-Kettering Cancer Center - Basking Ridge
		Leonard Bruce Saltz	Ph: 212-639-7202
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Stephen Scott Grubbs	Ph: 302-733-6227
	Long Branch
	Monmouth Medical Center
		Seth D Cohen	Ph: 732-923-7689
	Mount Holly
	Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
		Michael S. Entmacher	Ph: 888-847-8823
	Voorhees
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Michael S. Entmacher	Ph: 888-847-8823
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Ashwani Rajput	Ph: 877-275-7724
New York
	Commack
	Memorial Sloan-Kettering Cancer Center
		Leonard Bruce Saltz	Ph: 212-639-7202
	Middletown
	Tucker Center for Cancer Care at Orange Regional Medical Center
		Jeffrey M. Stewart	Ph: 845-342-7609
	New York
	Memorial Sloan-Kettering Cancer Center
		Leonard Bruce Saltz	Ph: 212-639-7202
	New York Weill Cornell Cancer Center at Cornell University
		Allyson J. Ocean	Ph: 212-746-1848
	Poughkeepsie
	Dyson Center for Cancer Care at Vassar Brothers Medical Center
		James R Nitzkorski	Ph: 845-483-6483
	Rockville Centre
	Memorial Sloan-Kettering Cancer Center - Rockville Centre
		Leonard Bruce Saltz	Ph: 212-639-7202
	Sleepy Hollow
	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
		Leonard Bruce Saltz	Ph: 212-639-7202
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Karyn B Stitzenberg	Ph: 877-668-0683
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Jaime L Bohl	Ph: 336-713-6771
North Dakota
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Preston D. Steen	Ph: 701-234-6161
		Preston D. Steen	Ph: 701-234-6161
	Sanford Clinic North-Fargo
		Preston D. Steen	Ph: 701-234-6161
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Grant R Seeger	Ph: 701-780-6520
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Jennifer E Payne	Ph: 330-375-6101
	Barberton
	Barberton Citizens Hospital
		Jennifer E Payne	Ph: 330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Kisa E Weeman	Ph: 330-363-6891
	Chillicothe
	Adena Regional Medical Center
		J. Philip Kuebler	Ph: 614-566-3275
	Cleveland
	Case Comprehensive Cancer Center
		Conor P Delaney	Ph: 800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce J. Averbook	Ph: 216-778-8526
			Email: kbauchens@metrohealth.org
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Carl R Schmidt	Ph: 866-627-7616
			Email: osu@emergingmed.com
	CCOP - Columbus
		J. Philip Kuebler	Ph: 614-566-3275
	Doctors Hospital at Ohio Health
		J. Philip Kuebler	Ph: 614-566-3275
	Grant Medical Center Cancer Care
		J. Philip Kuebler	Ph: 614-566-3275
	Mount Carmel Health - West Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Riverside Methodist Hospital Cancer Care
		J. Philip Kuebler	Ph: 614-566-3275
	Zangmeister Center
		J. Philip Kuebler	Ph: 614-566-3275
	Dayton
	CCOP - Dayton
		Howard M. Gross	Ph: 765-983-3000
	David L. Rike Cancer Center at Miami Valley Hospital
		Howard M. Gross	Ph: 317-783-8918
	Good Samaritan Hospital
		Howard M. Gross	Ph: 317-783-8918
	Grandview Hospital
		Howard M. Gross	Ph: 765-983-3000
	Samaritan North Cancer Care Center
		Howard M. Gross	Ph: 317-783-8918
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Findlay
	Blanchard Valley Regional Cancer Center
		Howard M. Gross	Ph: 317-783-8918
	Franklin
	Atrium Medical Center
		Howard M. Gross	Ph: 317-783-8918
	Greenville
	Wayne Hospital
		Howard M. Gross	Ph: 765-983-3000
	Kettering
	Charles F. Kettering Memorial Hospital
		Howard M. Gross	Ph: 317-783-8918
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler	Ph: 614-566-3275
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Mount Vernon
	Knox Community Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Portsmouth
	Southern Ohio Medical Center Cancer Center
		J. Philip Kuebler	Ph: 614-566-3275
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler	Ph: 614-566-3275
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Howard M. Gross	Ph: 765-983-3000
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler	Ph: 614-566-3275
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard M. Gross	Ph: 765-983-3000
	Zanesville
	Genesis - Good Samaritan Hospital
		J. Philip Kuebler	Ph: 614-566-3275
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Carla Kurkjian	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Alison K Conlin	Ph: 503-215-6412
	Milwaukie
	Providence Milwaukie Hospital
		Alison K Conlin	Ph: 503-215-6412
	Newberg
	Providence Newberg Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Oregon City
	Willamette Falls Hospital
		Alison K Conlin	Ph: 503-215-6412
	Portland
	CCOP - Columbia River Oncology Program
		Alison K Conlin	Ph: 503-215-6412
	Providence Cancer Center at Providence Portland Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Alison K Conlin	Ph: 503-215-6412
Pennsylvania
	Easton
	Easton Regional Cancer Center at Easton Hospital
		Rajen P Oza	Ph: 610-250-4000
	Furlong
	Fox Chase Cancer Center Buckingham
		Jeffrey M Farma	Ph: 215-728-4790
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		Wafik S El-Deiry	Ph: 717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Jeffrey M Farma	Ph: 215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Edith P. Mitchell	Ph: 215-955-6084
	Temple Cancer Center at Temple University Hospital
		Juhi Mittal	Ph: 215-728-2983
	Pittsburgh
	UPMC Cancer Centers
		Jennifer M Holder-Murray	Ph: 412-647-2811
	Pottstown
	Pottstown Memorial Regional Cancer Center
		Wei Song	Ph: 610-327-7544
Texas
	Houston
	Univeristy of Texas M.D. Anderson Cancer Center
		George J Chang	Ph: 713-792-3245
	Temple
	Scott and White Cancer Institute
		Lucas Wong	Ph: 254-724-5407
Utah
	Cedar City
	Sandra L. Maxwell Cancer Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Provo
	Utah Valley Regional Medical Center - Provo
		R. Jeffrey Lee	Ph: 801-507-3950
	Saint George
	Dixie Regional Medical Center - East Campus
		R. Jeffrey Lee	Ph: 801-507-3950
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Courtney Lynne Scaife	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	LDS Hospital
		R. Jeffrey Lee	Ph: 801-507-3950
	Utah Cancer Specialists at UCS Cancer Center
		R. Jeffrey Lee	Ph: 801-507-3950
Vermont
	Burlington
	Vermont Cancer Center at University of Vermont
		Steven Ades	Ph: 802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Traci L Hedrick	Ph: 434-243-6143
Washington
	Bellingham
	St. Joseph Cancer Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Bremerton
	Olympic Hematology and Oncology
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Issaquah
	Swedish Medical Center - Issaquah Campus
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Seattle
	Group Health Central Hospital
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	University Cancer Center at University of Washington Medical Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Spokane
	Cancer Care Northwest - Spokane South
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Alison K Conlin	Ph: 503-215-6412
	Southwest Washington Medical Center Cancer Center
		Alison K Conlin	Ph: 503-215-6412
	Wenatchee
	Wenatchee Valley Medical Center
		Gary E Goodman	Ph: 206-386-2323
			Email: patra.grevstad@swedish.org
Wisconsin
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Kirk A Ludwig	Ph: 414-805-4380
	Wauwatosa
	Oncology Alliance, SC - Milwaukee - West
		Rubina Qamar	Ph: 888-709-2080
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01515787
Information obtained from ClinicalTrials.gov on March 04, 2013

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