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	Treatment or Intervention	Phase
stage IB cervical cancer	Drug: cisplatin  Drug: vincristine	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• No prior therapy for cervical cancer
• No prior pelvic irradiation

--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

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

Study chairs or principal investigators

Gary Lee Eddy,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000078470; GOG-141
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002536
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08