KCT0005869
Recruiting
未知
Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
The Catholic University of Korea, Seoul St. Mary's Hospital0 sites360 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 360
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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\)
Outcomes
Primary Outcomes
Not specified
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