Clinical Trial: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

This study has been completed.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
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. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Condition Treatment or Intervention Phase
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
 Drug: cisplatin
 Procedure: adjuvant therapy
 Procedure: brachytherapy
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: radiation therapy
 Procedure: surgery
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 Study of Radical Hysterectomy and Tailored Chemoradiotherapy Versus Primary Chemoradiotherapy in Patients With Stage IB2 Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.
  • Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
  • Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
  • Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
  • Group 3: Patients receive further treatment at the discretion of the investigator.
  • Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
  • Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
  • Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
  • Group C: Patients receive no further treatment.
  • Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses. Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Adenosquamous carcinoma
  • Primary, previously untreated disease
  • Exophytic cervical lesions greater than 4 cm in diameter OR
  • Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
  • No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
  • No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
  • Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal

Renal

  • Creatinine no greater than 2.0 mg/dL
  • No renal abnormalities requiring modification of radiation fields

Gastrointestinal

Other

  • Not pregnant
  • Negative pregnancy test
  • No septicemia or severe infection
  • No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
  • No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  • No prior hysterectomy (total or subtotal)

Location Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States

      Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States

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

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States

      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612-3824,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States

Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States

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

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

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

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States

New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States

New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States

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

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

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0526,  United States

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

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States

      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States

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

      Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States

Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States

Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States

Japan
      Kagoshima City Hospital, Kagoshima City,  892-8580,  Japan

Study chairs or principal investigators

Scott McMeekin, MD,  Study Chair,  Oklahoma University Medical Center   

More Information

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

Study ID Numbers:  CDR0000269821; GOG-0201
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054067
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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