Phase III Trial of Stage I Ovarian Cancer After Surgery

Study Overview
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Brief Summary
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To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

Detailed Description
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Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types Facility where a subject is enrolled 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.

Official Title
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Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard therapy<br>combination of paclitaxel and carboplatin | Drug: adjuvant chemotherapy<br>* combination of paclitaxel and carboplatin<br>* Other names: paclitaxel and carboplatin;|
| No Intervention: Observation<br>Observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | In surviving patients, cut off will be on the last date the patient is confirmed to be alive. 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. | From date of randomization until the date of death from any cause, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | 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. Progression observed by CA-125 only shall not be handled as an event in this study. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epithelial ovarian cancer, FIGO stage I, staging surgery, adjuvant chemotherapy