Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery - JGOG3020 (ECO trial)

TANABE HIROSHI0 sites300 target enrollmentMarch 25, 2019

ConditionsEpithelial ovarian cancer Early OvarianCancer D000077216

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Epithelial ovarian cancer
Sponsor: TANABE HIROSHI
Enrollment: 300
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 25, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

TANABE HIROSHI

Eligibility Criteria

Inclusion Criteria

•1\).Patients with histopathologically confirmed epithelial ovarian cancer
•2\).Of patients with FIGO stage I (FIGO 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 (FIGO2014\) stage IC2, 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 for ovarian cancer
•9\) Patients who experienced serious drug hypersensitivity
•10\) Patients with peripheral neuropathy (motor and/or sensory) of Grade 2 or greater (CTCAE v4\.0\)