Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002536
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
PURPOSE Randomized phase III trial to compare surgery with or without chemotherapy in treating patients who have stage IB cervical cancer
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 45 years
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 45 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-141 | None | None | None |