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Not yet recruitingPhase 2/3

PDS Versus NACT-IDS in AI-Selected Advanced Epithelial Ovarian Cancer

Key facts

Who runs it
Shanghai Gynecologic Oncology Group
Where
China2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 2/3
People taking part
534 people, planned
Starts
31 Dec 2026
Expected to end
28 Feb 2037
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Upfront cytoreductive surgery
  • Interval debulking surgery
  • Platinum-based chemotherapy
Record updated
12 November 2026

Who can take part

Age
18 years to 79 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Female, aged ≥18 and <80 years
  • Newly diagnosed, pathologically confirmed stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. Diagnostic surgery, core-needle biopsy, or a pleural/ascitic fluid cell block may be used for confirmation as specified in the protocol
  • PET-CT based TNM clinical stage and cPCI tumor burden determined by multidisciplinary assessment
  • Eastern Cooperative Oncology Group performance status 0-2
  • Frailty index <0.15
  • Known BRCA1/2 status
  • MERITS recommendation for PDS and clinical eligibility for both randomized treatment strategies
  • Adequate bone marrow, renal, hepatic, and nutritional function to undergo chemotherapy and surgery: white blood cell count >3,000/µL; absolute neutrophil count ≥1,500/µL; platelets ≥100,000/µL; hemoglobin ≥9 g/dL; serum creatinine <1.25 × upper limit of normal or creatinine clearance ≥60 mL/min; total bilirubin <1.25 × upper limit of normal; ALT and AST <2.5 × upper limit of normal; and serum albumin >3.5 g/dL
  • Ability and willingness to comply with protocol treatment and scheduled follow-up
  • Written informed consent

Who cannot take part

  • Prior neoadjuvant chemotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapy for the current disease
  • Concurrent or uncontrolled malignancy diagnosed within the previous 5 years
  • Non-epithelial ovarian malignancy or borderline ovarian tumor
  • Severe systemic disease precluding surgery, including poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease, implanted cardiac pacemaker with clinically relevant comorbidity, moderately reduced cardiac ejection fraction, end-stage renal disease, myocardial infarction, cerebrovascular accident, uncontrolled infection, coagulation disorder, or another condition judged to make surgery or chemotherapy unsafe
  • Low-grade ovarian carcinoma, mucinous ovarian carcinoma, or clear cell carcinoma
  • Inability to complete the planned treatment course or follow-up
  • Religious, psychological, or other circumstances that could interfere with informed consent, protocol adherence, or follow-up

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 79 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This multicenter, open-label, randomized phase II/III trial will compare primary debulking surgery (PDS) with neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) in patients with newly diagnosed stage IIIC or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are recommended for PDS by the MERITS clinical decision tool and are clinically eligible for either treatment strategy.

The 2 groups in the trial

  • Primary Debulking SurgeryTreatment being tested

    Maximal-effort cytoreductive surgery will be completed within 3 weeks after pathologic diagnosis, followed by 6 cycles of first-line chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.

    Treatment: Upfront cytoreductive surgery and Platinum-based chemotherapy

  • Neoadjuvant Chemotherapy Followed by Interval Debulking SurgeryExisting treatment, for comparison

    Participants will receive 3 cycles of neoadjuvant chemotherapy, undergo interval debulking surgery with maximal-effort cytoreduction, and then receive 3 additional cycles of chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.

    Treatment: Interval debulking surgery and Platinum-based chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Artificial Intelligence -Assisted Randomized Phase II/III Trial of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer
Fit questions
Built from NCT07931313, who can take part
Record updated
12 November 2026