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