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Clinical Trials (PDQ®)

PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, Natural history/Epidemiology, TreatmentActive18 and overNCI, OtherCDR0000698428
CALGB-80803, NCT01333033

Trial Description

Summary

RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.

PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

Further Study Information

OBJECTIVES:

Primary

  • To induce a complete pathologic response (pCR) rate of 20% in positron emission tomography (PET) scan non-responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then crossover to the other regimen during radiotherapy.

Secondary

  • To compare PET/CT response between induction treatment arms.
  • To compare pCR between induction treatment arms among PET/CT scan responders.
  • To directly compare pCR between induction treatment arms among non-responders if both treatment regimens are found to be efficacious.
  • To determine 8-month progression-free survival (PFS) in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy.
  • Estimate the PFS and overall survival (OS) curves, overall and among PET responders and PET/CT non-responders by induction treatment.
  • To determine the rate of postoperative anastomotic leak after neoadjuvant chemotherapy followed by chemoradiation.
  • To evaluate immunohistochemistry and RT-PCR of ERCC1, and genetic polymorphisms of ERCC1, XPD, and XRCC1.
  • To evaluate status and levels of methylation of nine candidate biomarker genes as well as expression levels of selected specific microRNAs, which will be correlated with chemoradiation response.
  • To compare the quality of life (QOL) of responders and nonresponders (as determined by PET/CT scanning) to presurgical treatment for esophageal cancer, in terms of global QOL, physical symptoms, physical functioning, and emotional well-being.
  • To examine the association between OS and QOL in esophageal cancer patients treated with chemotherapy, chemoradiation therapy, and surgery.

OUTLINE: This is a multicenter study. Patients are stratified according to T-stage (T1-2 vs T3-4) and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by ≥ 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent radiotherapy (RT) (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to arm II during RT.
  • Arm II: Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases ≥ 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to arm I during RT.

Within 4-10 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgery at the discretion of the treating team.

Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Patients may also complete quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas Types 1 and 2
  • T1 N1-3 M0 or T2-4 N any M0 as determined by endoscopic ultrasound (EUS) and PET/CT (histologic confirmation of lymph involvement is not required)
  • All patients must have locoregional staging determined by EUS if technically feasible
  • All disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field
  • Endoscopy reports should clearly state both the T and N stage
  • No T4 tumor with clear evidence of invasion of the vertebral column, heart, great vessels, or tracheobronchial tree
  • No evidence of distant metastases (as determined by EUS or PET/CT)
  • Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible
  • Patient must have pre-resection tissue available for central pathology review
  • Patients must have detectable fluorine-18-labeled deoxyglucose (FDG) uptake on baseline PET/CT scan of primary tumor

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • AST/ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • No prior malignancy within 5 years, with the exception of basal or squamous cell skin cancers, or in situ bladder or cervical cancer
  • Patients with prior malignancy treated with surgery only and disease-free for more than 5 years are eligible
  • No history of severe hypersensitivity reaction to Cremaphor® EL
  • No known contraindication to the use of fluorouracil, taxanes, or platinum compounds

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior thoracic radiotherapy (RT), abdominal RT, or chemotherapy
  • No concurrent epoetin

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Karyn A. GoodmanPrincipal Investigator

Trial Sites

U.S.A.
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Rangaswamy Govindarajan Ph: 501-686-8274
California
  Palo Alto
 Palo Alto Medical Foundation
 David S Leibowitz Ph: 650-853-5757
  Email: hilld@pamf.org
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Alan Paul Venook Ph: 877-827-3222
 Veterans Affairs Medical Center - San Francisco
 Alan Paul Venook Ph: 877-827-3222
  Sunnyvale
 Palo Atlo Medical Foundation-Sunnyvale
 Peter P. Yu Ph: 408-730-2800
Connecticut
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
  New Haven
 Yale Cancer Center
 Daniel J Boffa Ph: 203-785-5702
  Norwich
 Eastern Connecticut Hematology and Oncology Associates
 Dennis E. Slater Ph: 860-886-8362
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kuakini Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Illinois
  Chicago
 Cancer and Leukemia Group B
 Karyn A Goodman Ph: 212-639-3983
  Email: goodmank@mskcc.org
 John H. Stroger, Jr. Hospital of Cook County
 Thomas E. Lad Ph: 312-864-6000
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Al Bowen Benson Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Victoria M Villaflor Ph: 773-834-7424
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Ronnie F Luyun Ph: 800-446-5532
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Rodney J. Landreneau Ph: 888-562-4763
Maine
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Robert D Hamilton Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Kansas City
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Albert Craig Lockhart Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Yungpo B Su Ph: 402-354-5144
New Jersey
  Basking Ridge
 Memorial Sloan-Kettering Cancer Center - Basking Ridge
 David H Ilson Ph: 212-639-7202
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Stephen Scott Grubbs Ph: 302-733-6227
  Englewood
 Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
 Minaxi Jhawer Ph: 201-894-3456
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Salma K Jabbour Ph: 732-235-8675
  Paramus
 The Valley Hospital-Luckow Pavilion
 Robert J Korst Ph: 201-634-5792
  Ridgewood
 Valley Hospital - Ridgewood
 Robert J Korst Ph: 201-634-5792
  Westwood
 Oncology Hematology and Internal Medicine
 Robert J Korst Ph: 201-634-5792
New York
  Buffalo
 Veterans Affairs Medical Center - Buffalo
 Lynn Marie Steinbrenner Ph: 716-862-3191
  Commack
 Memorial Sloan-Kettering Cancer Center
 David H Ilson Ph: 212-639-7202
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Vincent P. Vinciguerra Ph: 516-562-3467
  New Hyde Park
 Long Island Jewish Medical Center
 Vincent P. Vinciguerra Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Vincent P. Vinciguerra Ph: 516-562-3467
  New York
 Memorial Sloan-Kettering Cancer Center
 David H Ilson Ph: 212-639-7202
 Mount Sinai Medical Center
 Celina S Ang Ph: 212-824-7320
  Email: jenny.figueroa@mssm.edu
  Rockville Centre
 Memorial Sloan-Kettering Cancer Center - Rockville Centre
 David H Ilson Ph: 212-639-7202
  Syracuse
 SUNY Upstate Medical University Hospital
 Jonathan Wright Ph: 315-464-5476
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Michael L. Meyers Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Jonathan C Salo Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Cleveland
 Case Comprehensive Cancer Center
 Mitchell Machtay 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
 Karyn A Goodman
 Tanios Bekaii-Saab Ph: 866-627-7616
  Email: osu@emergingmed.com
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Mitchell Machtay Ph: 800-641-2422
  Oregon
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Shubham Pant Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Eliot Lawrence Friedman Ph: 610-402-2273
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Edith P. Mitchell Ph: 215-955-6084
  Pittsburgh
 UPMC Cancer Centers
 Michael K Gibson Ph: 800-641-2422
  Wynnewood
 CCOP - Main Line Health
 Albert S DeNittis Ph: 866-225-5654
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
South Carolina
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Christopher J Anker Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Vermont
  Berlin
 Mountainview Medical
 Steven Ades Ph: 802-656-8990
  Burlington
 Vermont Cancer Center at University of Vermont
 Steven Ades Ph: 802-656-8990
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Bhaumik B Patel Ph: 804-675-5646
Washington
  Seattle
 University Cancer Center at University of Washington Medical Center
 George E. Laramore Ph: 206-616-8289
Wisconsin
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Rezwan Islam Ph: 715-393-1400
  Marshfield
 Marshfield Clinic - Marshfield Center
 Rezwan Islam Ph: 715-393-1400
 Saint Joseph's Hospital
 Rezwan Islam Ph: 715-393-1400
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Candice A Johnstone Ph: 414-805-4380
  Email: cancerhelp@dartmouth.edu
  Minocqua
 Marshfield Clinic - Lakeland Center
 Rezwan Islam Ph: 715-393-1400
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Rezwan Islam Ph: 715-393-1400
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Rezwan Islam Ph: 715-393-1400
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Rezwan Islam Ph: 715-393-1400
 Saint Michael's Hospital Cancer Center
 Rezwan Islam Ph: 715-393-1400
  Weston
 Diagnostic and Treatment Center
 Rezwan Islam Ph: 715-393-1400
 Marshfield Clinic - Weston Center
 Rezwan Islam Ph: 715-393-1400

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01333033
ClinicalTrials.gov processed this data on January 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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