Comparing chemotherapy and observation for early-stage ovarian cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial aims to evaluate the overall survival of patients with stage I epithelial ovarian cancer who have undergone comprehensive staging surgery. Participants will be randomly assigned to receive either adjuvant chemotherapy or be placed in an observation group. The chemotherapy regimen may include combinations of Paclitaxel and Carboplatin or Docetaxel and Carboplatin, with treatment cycles determined by the participating facility's policy. The study will also consider various histologic types and staging factors to ensure appropriate patient stratification.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a diagnosis of histopathologically epithelial ovarian cancer
2. 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)
3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
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 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.
5. Age: 20 or older
6. Performance status (PS):0-1
7. Case with initial therapy for postoperative primary lesion
8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
9. Reasonable organ function
10. Patient must have signed informed consent.

Exclusion Criteria:

1. FIGO Stages Ic(a), Ic(1) and Ic(2)
2. Patients containing sarcoma elements
3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
4. Patients with serious complications
5. Patients with active infection
6. Patients with intestinal paralysis or intestinal obstruction
7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
8. Patients with previous chemotherapy or radiation therapy
9. Patients with serious drug hypersensitivity
10. Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\]
11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
12. 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.
13. Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Where it's running

• Aichi Medical University Hospital
  Nagakute-shi, Aichi-ken, Japan Recruiting
• Tosei General Hospital
  Seto-shi, Aichi-ken, Japan Recruiting
• Fujita Health University Hospital
  Toyoake-shi, Aichi-ken, Japan Recruiting
• Hirosaki University School of Medicine & Hospital
  Hirosaki-shi, Aomori, Japan Recruiting
• The Jikei University School of Medicine Kashiwa Hospital
  Kashiwa-shi, Chiba, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa-shi, Chiba, Japan Recruiting

+53 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Hiroshi Tanabe, M.D.
• Email: htanabe@east.ncc.go.jp
• Phone: 81-4-7133-1111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.