Trial Information

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

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.