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

July 8, 2013 updated by: Gynecologic Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Cervical Cancer

Intervention / Treatment

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 Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 phase III trial of the gynecologic oncology group. Gynecol Oncol. 2007 Aug;106(2):362-9. doi: 10.1016/j.ygyno.2007.04.007. Epub 2007 May 9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 25, 2004

First Posted (Estimate)

March 26, 2004

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

stage IB cervical cancer

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000078470
GOG-141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.