NCT04063527 Phase III Trial of Stage I Ovarian Cancer After Surgery
| NCT ID | NCT04063527 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Japanese Gynecologic Oncology Group |
| Condition | Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2012-07-20 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2012-07-20 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Eligibility Criteria
Inclusion Criteria: 1. Patients with a diagnosis of histopathologically epithelial ovarian cancer 2. FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type) 3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy. 4. 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. * Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed. * Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached. 5. Age: 20 or older 6. Performance status (PS):0-1 7. Case with initial therapy for postoperative primary lesion 8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery 9. Reasonable organ function 10. Patient must have signed informed consent. Exclusion Criteria: 1. FIGO Stages Ic(a), Ic(1) and Ic(2) 2. Patients containing sarcoma elements 3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT 4. Patients with serious complications 5. Patients with active infection 6. Patients with intestinal paralysis or intestinal obstruction 7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy 8. Patients with previous chemotherapy or radiation therapy 9. Patients with serious drug hypersensitivity 10. Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\] 11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 12. Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixed Hepatitis B virus (HBV)-DNA who are positive with either antigen-positive Hepatitis B (HBs), anti-hepatitis B core antigen or anti-hepatitis B surface antigen. 13. Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Contact & Investigator
Hiroshi Tanabe, M.D.
STUDY CHAIR
National Cancer Center Hospital East
Frequently Asked Questions
Who can join the NCT04063527 clinical trial?
This trial is open to female participants only, aged 20 Years or older, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04063527 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT04063527 currently recruiting?
Yes, NCT04063527 is actively recruiting participants. Contact the research team at htanabe@east.ncc.go.jp for enrollment information.
Where is the NCT04063527 trial being conducted?
This trial is being conducted at Nagakute-shi, Japan, Seto-shi, Japan, Toyoake-shi, Japan, Hirosaki-shi, Japan and 11 additional locations.
Who is sponsoring the NCT04063527 clinical trial?
NCT04063527 is sponsored by Japanese Gynecologic Oncology Group. The principal investigator is Hiroshi Tanabe, M.D. at National Cancer Center Hospital East. The trial plans to enroll 360 participants.
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