RecruitingPhase 3

Phase III Trial of Stage I Ovarian Cancer After Surgery

Japan360 participantsStarted 2012-07-20

Plain-language summary

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

Age range20 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 \[Retroperitoneal lymph node dissection\]).
✓. 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

✕. 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

Overall survival

Timeframe: From date of randomization until the date of death from any cause, assessed up to 60 months

NCT IDNCT04063527

SponsorJapanese Gynecologic Oncology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10-01

Hiroshi Tanabe, M.D.

Who can participate

Age range20 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 \[Retroperitoneal lymph node dissection\]).
✓. 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

✕. 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