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

10. april 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2003

Primær færdiggørelse (Faktiske)

1. april 2005

Datoer for studieregistrering

Først indsendt

5. februar 2003

Først indsendt, der opfyldte QC-kriterier

5. februar 2003

Først opslået (Skøn)

6. februar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000269821
  • GOG-0201

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner