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

Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

Phase 3 Interventional Japanese Gynecologic Oncology Group · NCT04063527

This study is testing whether giving chemotherapy after surgery helps women with early-stage ovarian cancer live longer compared to just monitoring their condition.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages20 Years and up
SexFemale
SponsorJapanese Gynecologic Oncology Group Academic / other
Drugs / interventionschemotherapy, radiation
Locations103 sites (Nagakute-shi, Aichi-ken and 102 other locations)
Trial IDNCT04063527 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with histopathologically confirmed stage I epithelial ovarian cancer who have undergone comprehensive staging surgery.

Not a fit: Patients with advanced-stage ovarian cancer or those who have not undergone the required surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of adjuvant chemotherapy in improving survival rates for patients with early-stage ovarian cancer.

How similar studies have performed: Previous studies have shown promising results with adjuvant chemotherapy in ovarian cancer, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Nagakute-shi, Aichi-ken and 102 other locations

+53 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Epithelial Ovarian Cancerepithelial ovarian cancerFIGO stage Istaging surgeryadjuvant chemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.