Status:
RECRUITING
Phase III Trial of Stage I Ovarian Cancer After Surgery
Lead Sponsor:
Japanese Gynecologic Oncology Group
Collaborating Sponsors:
Korean Gynecologic Oncology Group
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
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 ade...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of histopathologically epithelial ovarian cancer
- 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)
- Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
- 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.
- Age: 20 or older
- Performance status (PS):0-1
- Case with initial therapy for postoperative primary lesion
- Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
- Reasonable organ function
- Patient must have signed informed consent.
Exclusion
- FIGO Stages Ic(a), Ic(1) and Ic(2)
- Patients containing sarcoma elements
- Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
- Patients with serious complications
- Patients with active infection
- Patients with intestinal paralysis or intestinal obstruction
- Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
- Patients with previous chemotherapy or radiation therapy
- Patients with serious drug hypersensitivity
- Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\]
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- 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.
- Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Key Trial Info
Start Date :
July 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04063527
Start Date
July 20 2012
End Date
February 1 2030
Last Update
August 30 2019
Active Locations (103)
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1
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan, 480-1195
2
Tosei General Hospital
Seto-shi, Aichi-ken, Japan, 489-8642
3
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan, 470-1193
4
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan, 036-8563