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

2013년 4월 10일 업데이트: Gynecologic Oncology Group

Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation

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: Randomized phase 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

OBJECTIVES:

  • Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the health-related quality of life of patients treated with these regimens.

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

  • Arm I: (Surgery followed by chemoradiotherapy): 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.

    • Aborted hysterectomy: 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.

    • Completed hysterectomy: 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.

연구 유형

중재적

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, 미국, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Los Angeles, California, 미국, 90095-1740
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Gatos, California, 미국, 95032
        • Women's Cancer Center at Community Hospital of Los Gatos
      • Orange, California, 미국, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
    • Connecticut
      • New Haven, Connecticut, 미국, 06520-8028
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, 미국, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, 미국, 20307-5001
        • Walter Reed Army Medical Center
    • Illinois
      • Chicago, Illinois, 미국, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, 미국, 60612
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, 미국, 60612-3824
        • Rush-Presbyterian-St. Luke's Medical Center
      • Decatur, Illinois, 미국, 62794-9640
        • CCOP - Central Illinois
      • Evanston, Illinois, 미국, 60201
        • CCOP - Evanston
      • Urbana, Illinois, 미국, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, 미국, 46202-5289
        • Indiana University Cancer Center
      • South Bend, Indiana, 미국, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City, Iowa, 미국, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Bethesda, Maryland, 미국, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Grand Rapids, Michigan, 미국, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, 미국, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Saint Louis Park, Minnesota, 미국, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson, Mississippi, 미국, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, 미국, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, 미국, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, 미국, 65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha, Nebraska, 미국, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • Camden, New Jersey, 미국, 08103-1489
        • Cooper University Hospital
    • New York
      • New York, New York, 미국, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, 미국, 11790-7775
        • Long Island Cancer Center at Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, 미국, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45267-0526
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, 미국, 44106
        • Ireland Cancer Center
      • Columbus, Ohio, 미국, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oregon
      • Portland, Oregon, 미국, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington, Pennsylvania, 미국, 19001-3788
        • Abington Memorial Hospital
      • Danville, Pennsylvania, 미국, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey, Pennsylvania, 미국, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, 미국, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, 미국, 19104-4283
        • Abramson Cancer Center at University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, 미국, 15213-3180
        • Magee-Womens Hospital
    • Tennessee
      • Knoxville, Tennessee, 미국, 37917
        • Southeast Gynecologic Oncology Associates
      • Nashville, Tennessee, 미국, 37232-2516
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Galveston, Texas, 미국, 77555-0587
        • University of Texas Medical Branch
      • Houston, Texas, 미국, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Temple, Texas, 미국, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, 미국, 05401
        • Fletcher Allen Health Care - Medical Center Campus
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792-6188
        • University of Wisconsin Comprehensive Cancer Center
  • 일본
      • Kagoshima City, 일본, 892-8580
        • Kagoshima City Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

  • No gastrointestinal bleeding
  • No intestinal obstruction

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gynecologic Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: D. Scott McMeekin, MD, Oklahoma University Cancer Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2003년 2월 1일

기본 완료 (실제)

2005년 4월 1일

연구 등록 날짜

최초 제출

2003년 2월 5일

QC 기준을 충족하는 최초 제출

2003년 2월 5일

처음 게시됨 (추정)

2003년 2월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 4월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 4월 10일

마지막으로 확인됨

2013년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDR0000269821
  • GOG-0201

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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