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Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002536
Collaborator
National Cancer Institute (NCI) (NIH)
41
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase III trial to compare surgery with or without chemotherapy in treating patients who have stage IB cervical cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: cisplatin
  • Drug: vincristine sulfate
  • Procedure: surgical procedure
  • Radiation: radiation therapy
 Phase 3

Detailed Description

OBJECTIVES: I. Compare disease free survival, overall survival, and local control in patients with bulky stage IB carcinoma of the cervix treated with radical hysterectomy and pelvic and para-aortic lymphadenectomy with or without neoadjuvant vincristine and cisplatin. II. Compare adverse effects of radical hysterectomy and pelvic and para-aortic lymphadenectomy with or without neoadjuvant vincristine and cisplatin in these patients.

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

Surgery. All patients undergo intra-abdominal and retroperitoneal exploratory laparotomy. Patients without metastases also undergo radical hysterectomy with pelvic and para-aortic lymphadenectomy. Beginning 2-4 weeks after surgery, patients with 1 or more positive lymph nodes or positive surgical margins on the radical hysterectomy specimen receive adjunctive radiotherapy 5 days each week for 4-6 weeks. Patients with histologically confirmed metastases do not undergo radical hysterectomy with pelvic and para-aortic lymphadenectomy, but receive radiotherapy 5 days each week for 6-8 weeks beginning 2-4 weeks after the laparotomy. Patients who undergo radiotherapy also receive cisplatin IV over 1 hour on days when radiotherapy is administered for up to 6 doses of cisplatin. Arm II: Patients receive vincristine IV bolus immediately followed by cisplatin IV over 1 hour on days 1, 11, and 21. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning approximately 4 weeks after the last doses of neoadjuvant vincristine and cisplatin, patients receive surgery, radiotherapy, and cisplatin as in Arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 170-340 patients will be accrued for this study over approximately 4.5 years.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
TREATMENT OF PATIENTS WITH SUBOPTIMAL ('BULKY') STAGE IB CARCINOMA OF THE CERVIX: A RANDOMIZED COMPARISON OF RADICAL HYSTERECTOMY AND PELVIC AND PARA-AORTIC LYMPHADENECTOMY WITH OR WITHOUT NEOADJUVANT VINCRISTINE AND CISPLATIN CHEMOTHERAPY, PHASE III
Study Start Date :
Dec 1, 1996
Actual Primary Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Previously untreated, histologically proven invasive carcinoma of the cervix Eligible histologies: Squamous Adenocarcinoma Adenosquamous Eligible stages: Bulky stage IB, i.e.: Exophytic lesions 4 cm or greater in diameter OR Cervix expanded to 4 cm or greater and presumed clinically to result from cancer No extension beyond cervix clinically and by IVP or CT with contrast

    PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No septicemia or severe infection No other concurrent malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer and prior malignancy therapy does not contraindicate current protocol therapy Suitability for radical hysterectomy and lymphadenectomy required

    PRIOR CONCURRENT THERAPY: No prior therapy for cervical cancer No prior pelvic irradiation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Southern California Permanante Medical Group Bellflower California United States 90706
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Community Hospital of Los Gatos Los Gatos California United States 95032
    5 Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 University of Colorado Cancer Center Denver Colorado United States 80010
    7 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    8 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    9 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    10 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    11 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    12 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    13 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    14 Tufts University School of Medicine Boston Massachusetts United States 02111
    15 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    16 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    17 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    18 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    19 Washington University School of Medicine Saint Louis Missouri United States 63110
    20 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    21 Morristown Memorial Hospital Morristown New Jersey United States 07962-1956
    22 Cancer Center of Albany Medical Center Albany New York United States 12208
    23 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    24 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    25 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    26 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    27 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    28 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    29 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    30 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    31 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    32 Abington Memorial Hospital Abington Pennsylvania United States 19001
    33 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    34 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    35 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    36 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    37 Brookview Research, Inc. Nashville Tennessee United States 37203
    38 Fletcher Allen Health Care Burlington Vermont United States 05401
    39 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    40 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    41 Tacoma General Hospital Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Gary L. Eddy, MD, Kaiser Permanente Medical Center - Bellflower

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002536
    Other Study ID Numbers:
    • CDR0000078470
    • GOG-141
    First Posted:
    Mar 26, 2004
    Last Update Posted:
    Jul 9, 2013
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    stage IB cervical cancer
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Vincristine

    Study Results

    No Results Posted as of Jul 9, 2013