Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Vincristine
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

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