Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00002536|
Recruitment Status : Completed
First Posted : March 26, 2004
Last Update Posted : July 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: cisplatin Drug: vincristine sulfate Procedure: surgical procedure Radiation: radiation therapy||Phase 3|
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 (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|
|Study Start Date :||December 1996|
|Primary Completion Date :||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002536
Show 41 Study Locations
|Study Chair:||Gary L. Eddy, MD||Kaiser Permanente Medical Center - Bellflower|