Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190528
Status:
TERMINATED
Last Update Posted:
2016-09-22
First Post:
2005-09-13
Brief Title:
A Trial of Neoadjuvant Chemotherapy Surgery vs Surgery for Bulky Stage III Cervical Cancer
Sponsor:
Haruhiko Fukuda
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Bulky Stage III Cervical Cancer Japan Clinical Oncology Group Trial JCOG0102
Status:
TERMINATED
Status Verified Date:
2016-09
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:
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage III cervical cancer
Detailed Description:
We designed this randomized study to investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage III cervical cancer Patients with FIGO stage III with bulky disease are randomized to either neoadjuvant chemotherapy BOMP Cisplatin 14mgm2 day 1-5 Bleomycin 7mg day 1-5 Mitomycin 7mgm2 day 5 and Vincristine 07mgm2 day every 21 days for 2-4 cycles followed by radical hysterectomy or radical hysterectomy alone The primary endpoint is overall survival and the secondary endpoints are progression-free survival complication of surgery completeness of radical hysterectomy omission of postsurgical irradiation completeness of postsurgical irradiation response rate and adverse events A total 200 patients 100 per treatment arm planned to accrue for this study within 55 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 |
|---|---|---|---|
| C000000194 | None | None | None |