A Phase 3 interventional study of adjuvant chemotherapy in Epithelial Ovarian Cancer, sponsored by Japanese Gynecologic Oncology Group. Recruiting at 103 sites in 2 countries. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Japanese Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 360 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Japanese Gynecologic Oncology Group is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum ([Peritoneal biopsy] see details below), retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph node dissection]).
However, for the following cases, it is eligible as a condition to record on the official document.
Exclusion Criteria:
combination of paclitaxel and carboplatin
Drug: adjuvant chemotherapy
Observation
combination of paclitaxel and carboplatin
Also known as: paclitaxel and carboplatin
Overall survival
1. In surviving patients, cut off will be on the last date the patient is confirmed to be alive. 2. If a patient is lost to follow-up, cut off will be on the last date the patient is confirmed to be alive before being lost to follow-up.
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Relapse-free survival
1. If relapse is diagnosed through imaging, it is considered an event on the "test date" on which a "definite diagnosis" is obtained and not the test date that showed a "suspected relapse on an image." If a relapse is clinically diagnosed, not just through imaging, it is considered an event on the date on which relapse is diagnosed. 2. Progression observed by CA-125 only shall not be handled as an event in this study.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Showing the first 100 of 103 sites across 2 countries.
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Japanese Gynecologic Oncology Group