Clinical Trial: Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage IVA cancer of the cervix .

Condition Treatment or Intervention Phase
cervical squamous cell carcinoma
cervical adenocarcinoma
stage IIB cervical cancer
stage III cervical cancer
cervical adenosquamous cell carcinoma
stage IVA cervical cancer
 Drug: cisplatin
 Drug: fluorouracil
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Comparison Study of Radiotherapy vs Radiotherapy Plus Cisplatin vs Radiotherapy Plus Fluorouracil in Patients With Uterine Cervix Carcinoma

Further Study Details: 

Study start: October 1997

OBJECTIVES: I. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis receiving either radiotherapy alone, or radiotherapy plus weekly cisplatin, or radiotherapy plus prolonged venous infusion (PVI) of fluorouracil. [Radiotherapy alone regimen closed 8/18/98]

II. Determine the relative toxic effects of radiation therapy plus chemotherapy with either weekly cisplatin or PVI fluorouracil compared to radiation alone. [Radiotherapy alone regimen closed 8/18/98]

IV. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus non-smokers and those who smoke during radiation therapy versus those who quit.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by stage, performance of para-aortic lymphadenectomy, and brachytherapy method (HDR vs LDR).

Prior to treatment patients complete a questionnaire regarding past and present smoking history and exposure to secondhand smoke.

In arm I, patients undergo external radiation therapy to the pelvis once daily 5 times a week for 5 weeks. Then, patients receive either low dose rate or high dose rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a week, respectively. If intracavitary radiation therapy cannot be performed, then shrinking field technique is executed. In addition, patients receive parametrial boost once daily for 3 to 5 days during intracavitary brachytherapy. Concurrently, patients receive IV cisplatin once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the parametrial boost.

Patients in arm II receive external radiation therapy and brachytherapy as previously described. [Arm II closed 8/18/98]

In arm III, patients undergo external radiation therapy as described in arm I. In addition, patients receive prolonged venous infusion (PVI) fluorouracil daily for 5 days during external beam radiation therapy (whole pelvis and parametrial boost).

If all 6 courses of cisplatin or fluorouracil cannot be administered during external radiation therapy, then the sixth course of chemotherapy will be given during brachytherapy.

Patients are followed every 3 months for the first 2 years, then every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue a maximum of 870 patients over 66 months.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: No prior cytotoxic chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: No prior radiation therapy to the pelvis
  • Surgery: No prior hysterectomy

--Patient Characteristics--

  • Age: Any age
  • Performance status: GOG 0-3
  • Life expectancy: Not specified
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 times normal; SGOT and alkaline phosphatase no greater than 3 times normal
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Other: No septicemia or severe infection; Not pregnant; Negative pregnancy test; Effective contraception required of fertile patients; No other invasive malignancy unless disease free for at least 5 years and no prior cancer treatment that contraindicated this protocol therapy; No concomitant malignancy other than nonmelanomatous skin cancer; Must complete smoking history questionnaire and provide urine specimen for cotinine analysis

Location Information


Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

      Women's Cancer Center, Palo Alto,  California,  94304,  United States

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States

District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      Fred J. Woods Radiation Therapy Center/St. Joseph's Cancer Institute, Tampa,  Florida,  33607,  United States

      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States

      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States

Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States

      Medicine Branch, Bethesda,  Maryland,  20892,  United States

      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States

Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States

New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States

New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States

      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-9832,  United States

      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States

North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States

      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States

      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Oklahoma
      CCOP - Sooner State, Tulsa,  Oklahoma,  74136,  United States

      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States

      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States

      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States

      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States

      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States

South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States

      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States

Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States

Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States

      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Canada, Ontario
      NCIC-Clinical Trials Group, Kingston,  Ontario,  K7L 3N6,  Canada

Study chairs or principal investigators

Rachelle M. Lanciano,  Study Chair,  Gynecologic Oncology Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065771; GOG-165
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003078
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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