Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 360

Inclusion Criteria

1). Patients with histopathologically confirmed epithelial ovarian cancer
2). Of patients with FIGO(Intermational Federation of Gynecologic and Obstetrics) stage I (FIGO(Intermational Federation of Gynecologic and Obstetrics), 2014), patients with stage IA (clear cell adenocarcinoma or Grade 2/3 other histologic type), IB (clear cell adenocarcinoma or Grade 2/3 other histologic type), and IC1 (all histologic types and differentiations) patients
3). Patients whose cancer staging was determined by comprehensive staging surgery or re-staging surgery (ovarian cancer was diagnosed at initial surgery and then another surgery was performed to determine the cancer stage). However, for patients with re- staging surgery, the surgery must have been performed within 12 weeks after initial surgery. It is acceptable that a biopsy of various sites of the peritoneum were performed during the re-staging surgery if findings for sub-classification of the cancer staging during the initial surgery were convincing, such as peritoneal cytology result and tumor capsule rupture status: either spontaneous rupture or rupture during surgery.
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 keep a record on the official document.
· Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site during open surgery, and the case that biopsy has not been performed. (Peritoneal biopsy is mandatory when the surgery is other than open surgery)
· 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). Patients aged 20 years or older at the time of enrollment
6). Patients with an ECOG Performance Status (P.S.) of 0 to 1
7). Patients for whom this is the initial treatment for the primary lesion after surgery (no history of chemotherapy and radiotherapy. Intraperitoneal administration of anticancer drugs during surgery is also not acceptable
8). Patents who are able to start adjuvant chemotherapy within 8 weeks after staging surgery or re-staging surgery.
9). Patients whose main organ functions (including bone marrow, heart, liver, and kidneys) have been maintained
These tests should be performed within 14 days prior to enrollment.
10). Patients who have consented in writing to participate in this study

Exclusion Criteria

1). FIGO (FIGO(Intermational Federation of Gynecologic and Obstetrics), 2014) stage IC2, or IC3 patients
2). Patients with cancer containing sarcoma components
3). Patients with possible interstitial pneumonia or pulmonary fibrosis by plain chest X- rays and CT
4). Patients with serious complication
5). Patients with apparent infection
6). Patients with paralysis intestinal or intestinal obstruction
7). Patients with active double cancer, or double cancer patients with disease-free interval of less than 5 years (lesions equivalent to carcinoma in situ and intramucosal carcinoma are excluded as active double cancers)
8). Patients with a history of chemotherapy or radiotherapy
9). Patients who experienced serious drug hypersensitivity
10). Patients with peripheral neuropathy (motor and/or sensory) of Grade 2 or greater (CTCAE v4.0)
11). Patients with a history of hypersensitivity to drug products containing polysorbate 80, polyoxyethylene castor oil (Cremophor EL) (such as cyclosporine), or hydrogenated castor oil (such as vitamins for injections)
12). Patients that are either HBs antigen-positive, HBc antibody or HBs antibody (or both) that are positive for a measured value of more than 2.1 log copies/ml.
13). Any other patients whose investigators determine them to be inappropriate to enter into the clinical study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definition of overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival;Definition of the last date of confirmation of relapse free survival;Adverse Events

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