Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112086
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2005-05-27
Brief Title:
OVCA-NAC-P2 Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian Tubal and Peritoneal Cancers JCOG0206
Sponsor:
Japan Clinical Oncology Group
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage IIIIV Ovarian Tubal and Peritoneal Cancers JCOG0206
Status:
COMPLETED
Status Verified Date:
2016-08
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:
A feasibility study of neoadjuvant chemotherapy NAC followed by interval cytoreductive surgery ICS and postoperative chemotherapy for stage IIIIV mullerian carcinomas such as ovarian tubal and peritoneal carcinomas
Detailed Description:
The purposes are to assess the safety and efficacy of the treatment starting with NAC and to know whether we can accurately diagnose these advanced carcinomas by imaging studies cytologic findings and tumor markers without staging laparotomy or laparoscopy Fifty-six patients with advanced mullerian carcinomas will be recruited to the study After confirmation of diagnosis by laparoscopic inspection and biopsies patients undergo 4 cycles of chemotherapy as NAC followed by ICS and additional 4 cycles of postsurgical chemotherapy The primary endpoint is proportion of clinical complete remission after accomplishment of the protocol treatment and the major secondary endpoint is positive predictive value of diagnosis before laparoscopy regarding tumor origin histology and stage Based on the result of this study we will conduct a phase III study to compare the treatment starting with NAC and primary cytoreductive surgery followed by postsurgical chemotherapy
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 |
|---|---|---|---|
| C000000005 | None | None | None |