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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gynecologic Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2003

Primaire voltooiing (Werkelijk)

1 april 2005

Studieregistratiedata

Eerst ingediend

5 februari 2003

Eerst ingediend dat voldeed aan de QC-criteria

5 februari 2003

Eerst geplaatst (Schatting)

6 februari 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

11 april 2013

Laatste update ingediend die voldeed aan QC-criteria

10 april 2013

Laatst geverifieerd

1 april 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000269821
  • GOG-0201

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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