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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002536
• Other study ID #: CDR0000078470
• Secondary ID: GOG-141
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 8, 2013
• Start date: December 1996

Study information

• Verified date: March 2008
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• cisplatin

• vincristine sulfate

Procedure:
• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Southern California Permanante Medical Group	Bellflower	California
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Eddy GL, Bundy BN, Creasman WT, Spirtos NM, Mannel RS, Hannigan E, O'Connor D. Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: a ph — View Citation