Phase III Trial of Stage I Ovarian Cancer After Surgery

Recruiting now · Phase 3

Conditions studied: Epithelial Ovarian Cancer

In brief

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

Key facts

Study ID

NCT04063527

Run by

Japanese Gynecologic Oncology Group

People needed

360

Starts

2012-07-20

Expected to finish

2030-02-01

Last updated by the study team

2019-08-30

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tosei General Hospital — Seto-shi, Aichi-ken, Japan (enrolling)
• Fujita Health University Hospital — Toyoake-shi, Aichi-ken, Japan (enrolling)
• Hirosaki University School of Medicine & Hospital — Hirosaki-shi, Aomori, Japan (enrolling)
• The Jikei University School of Medicine Kashiwa Hospital — Kashiwa-shi, Chiba, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (enrolling)
• Ehime University Hospital — Onsen-gun, Ehime, Japan (enrolling)
• Kyusyu Medical Center — Fukuoka, Fukuoka, Japan (enrolling)
• Kyusyu Cancer Center — Fukuoka, Fukuoka, Japan (enrolling)
• Kyushu University Hospital — Fukuoka, Fukuoka, Japan (enrolling)
• Kurume University Hospital — Kurume-shi, Fukuoka, Japan (enrolling)
• Gifu University Hospital — Gifu, Gifu, Japan (enrolling)
• Gunma University Hospital — Maebashi, Gunma, Japan (enrolling)
• Gunma Prefectural Cancer Center — Ōta, Gunma, Japan (enrolling)
• JA Hiroshima General Hospital — Hatsukaichi-shi, Hiroshima, Japan (enrolling)
• Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Hiroshima, Japan (enrolling)
• Hiroshima Prefectural Hospital — Hiroshima, Hiroshima, Japan (enrolling)
• Miyoshi Central Hospital — Miyoshi-shi, Hiroshima, Japan (enrolling)
• Hospital Hakodate Hokkaido — Hakodate-shi, Hokkaido, Japan (enrolling)
• JA Sapporo-Kosei general Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Hokkaido University Hospita — Sapporo, Hokkaido, Japan (enrolling)
• Hyogo Cancer Center — Akashi-shi, Hyōgo, Japan (enrolling)
• Kansai Rosai Hospital — Amagasaki-shi, Hyōgo, Japan (enrolling)
• Japanese Red Cross Society Himeji Hospital — Himeji-shi, Hyōgo, Japan (enrolling)
• University of Tsukuba Hospital — Tsukuba, Ibaraki, Japan (enrolling)
• Aichi Medical University Hospital — Nagakute-shi, Aichi-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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