Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04063527
Status:
RECRUITING
Last Update Posted:
2019-08-30
First Post:
2019-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Trial of Stage I Ovarian Cancer After Surgery
Sponsor:
Japanese Gynecologic Oncology Group
Organization:
Study Overview
Official Title:
Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
Status:
RECRUITING
Status Verified Date:
2019-08
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:
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Detailed Description:
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.
1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types
2. Facility where a subject is enrolled
3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/ Ib vs. Stage Ic(b)
Group A: adjuvant chemotherapy group (standard treatment group):
While one of the following treatments will be performed, the number of cycles is entrusted to the treatment policy of each facility.
Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA) area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy; Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles
After the start of TC therapy, switching from PTX to DTX due to an adverse event is permitted.
Group B: observation group (study treatment group): Observation only, no adjuvant chemotherapy administered.
1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types
2. Facility where a subject is enrolled
3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/ Ib vs. Stage Ic(b)
Group A: adjuvant chemotherapy group (standard treatment group):
While one of the following treatments will be performed, the number of cycles is entrusted to the treatment policy of each facility.
Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA) area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy; Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles
After the start of TC therapy, switching from PTX to DTX due to an adverse event is permitted.
Group B: observation group (study treatment group): Observation only, no adjuvant chemotherapy administered.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: