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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2003

Primær fullføring (Faktiske)

1. april 2005

Datoer for studieregistrering

Først innsendt

5. februar 2003

Først innsendt som oppfylte QC-kriteriene

5. februar 2003

Først lagt ut (Anslag)

6. februar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000269821
  • GOG-0201

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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