In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, OtherRTOG 0724
CDR0000654709, NCI-2011-01973, NCT00980954

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, 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 and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

Further Study Information

OBJECTIVES:

Primary

  • To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.

Secondary

  • To evaluate adverse events.
  • To evaluate overall survival.
  • To evaluate quality of life.
  • To evaluate chemotherapy-induced neuropathy.
  • To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy (IMRT) with respect to toxicity and local control.
  • To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.
  • To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify single nucleotide polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - [standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.

NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

  • Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.

Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies.

After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
  • Positive pelvic nodes
  • Positive parametrium
  • Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative
  • PET only required if positive para-aortic nodes during surgery
  • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
  • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
  • Para-aortic and pelvic node sampling required
  • If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
  • A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
  • No gross residual disease
  • No neuroendocrine histology
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelets ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 4,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
  • Alkaline phosphatase normal
  • Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥ 350/mm³ within the past 14 days
  • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
  • Coagulation defects
  • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy for the current cervical cancer
  • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Anuja JhingranPrincipal Investigator

Trial Sites

U.S.A.
Alaska
  Anchorage
 Providence Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
Arizona
  Peoria
 Arizona Center for Cancer Care - Peoria
 Christopher A Biggs Ph: 623-773-2873
  Phoenix
 St. Joseph's Hospital and Medical Center
 John H Farley Ph: 877-602-4111
California
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Matthew C Solhjem Ph: 503-215-6412
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Anuja Jhingran
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 Krishnansu S Tewari Ph: 714-456-6191
  Email: awallick@uci.edu
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Yallapragada S. Rao Ph: 909-865-9555
  Sacramento
 Sutter Cancer Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Saint Helena
 Saint Helena Hospital
 David J Tate Ph: 707-967-3698
Colorado
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Andrew L Salner Ph: 860-545-5363
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
Florida
  Deerfield Beach
 University of Miami/Deerfield Beach
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Kissimmee
 Florida Hospital Kissimmee
 Robert J Sollaccio Ph: 407-303-5623
  Miami
 Jackson Memorial Hospital
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
Georgia
  Gainesville
 Northeast Georgia Medical Center
 Frank G. Lake Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 James J Burke Ph: 912-350-8568
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 John A Pablo Ph: 800-622-6877
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-4673
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Eric D Donnelly Ph: 312-695-1301
  Email: cancer@northwestern.edu
 Rush Cancer Institute at Rush University Medical Center
 Krystyna D. Kiel Ph: 312-942-5498
  Email: clinical_trials@rush.edu
  Peoria
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 David H Moore Ph: 317-851-2555
  Hammond
 Oncology Center at Saint Margaret Mercy Healthcare Center
 Robert D Prock Ph: 708-891-9305
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Binh N Tran Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Anuja Jhingran
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Parvesh Kumar Ph: 913-588-4709
  Overland Park
 Kansas City Cancer Centers - Southwest
 Parvesh Kumar Ph: 913-588-4709
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
  Silver Spring
 Holy Cross Hospital
 Sheela D Modin Ph: 310-754-7552
Michigan
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Samir Narayan Ph: 734-712-4673
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Samir Narayan Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-4673
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Kansas City
 Kansas City Cancer Centers - North
 Parvesh Kumar Ph: 913-588-4709
 Kansas City Cancer Centers - South
 Parvesh Kumar Ph: 913-588-4709
  Lee's Summit
 Kansas City Cancer Centers - East
 Parvesh Kumar Ph: 913-588-4709
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New Hampshire
  Manchester
 Elliot Regional Cancer Center at Elliot Hospital
 Brian R Knab Ph: 603-663-1800
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Tamara A LaCouture Ph: 856-325-6757
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Brian M Slomovitz Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Lemuel S. Ariaratnam Ph: 888-847-8823
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Tamara A LaCouture Ph: 856-325-6757
New York
  Brooklyn
 SUNY Downstate Medical Center
 Marvin Rotman Ph: 718-270-8216
  Email: sima.terebelo@downstate.edu
  New York
 Memorial Sloan-Kettering Cancer Center
 Mario M Leitao Ph: 212-639-7202
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Robert Victor Higgins Ph: 704-355-2884
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Douglas David Martin Ph: 866-627-7616
  Email: osu@emergingmed.com
 Anuja Jhingran
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Stephanie A. King Ph: 215-728-4790
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Knoxville
 U.T. Medical Center Cancer Institute
 Larry C Kilgore Ph: 865-544-9773
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Ann H Klopp
  Email: aklopp@mdanderson.org
 Methodist Hospital
 Aparna A Kamat Ph: 713-790-2700
 Univeristy of Texas M.D. Anderson Cancer Center
 Ann H Klopp Ph: 713-792-3245
Utah
  Logan
 Logan Regional Hospital
 Anuja Jhingran
  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
  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
 David K. Gaffney Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Washington
  Seattle
 Seattle Cancer Care Alliance
 Heidi J Gray Ph: 206-616-8289
  Yakima
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
West Virginia
  Wheeling
 Schiffler Cancer Center at Wheeling Hospital
 Jon David Pollock Ph: 304-243-6442
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Beth Ann Erickson Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Ali Mahdavi Ph: 414-649-5717
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Ali Mahdavi Ph: 414-649-5717
Canada
Quebec
  Montreal
 McGill Cancer Centre at McGill University
 Luis Souhami Ph: 514-934-1934ext42953
  Email: evelyn.ortega@muhc.mcgill.ca
Hong Kong
  Chai Wan
 Pamela Youde Nethersole Eastern Hospital
 Inda Sung Soong Ph: 888-823-5923
  Email: ctsucontact@westat.com
Republic of Korea
  Seoul
 Gangnam Severance Hospital
 Jae-Hoon Kim
  Email: clinical.trial@bms.com
 Korea Cancer Center Hospital
 Sang Y Ryu Ph: 011-82-02-9702-114
 Seoul National University Hospital
 Jae W Kim Ph: 011-82-760-2384

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00980954
ClinicalTrials.gov processed this data on November 12, 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.

Back to TopBack to Top