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

November 10, 2026 updated by: Shanghai Gynecologic Oncology Group

Artificial Intelligence -Assisted Randomized Phase II/III Trial of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The optimal timing of cytoreductive surgery in advanced epithelial ovarian cancer remains uncertain. Earlier randomized trials did not clearly identify which patients benefit from PDS rather than NACT-IDS. Using data from 489 participants in the SUNNY trial, the Multi-Endpoint RMST Ensemble for Individualized Treatment Selection (MERITS) model was developed and internally evaluated in the previous SUNNY-AI trial (NCT06839157). The model uses seven pretreatment clinical variable groups: BRCA status, TNM stage, Eastern Cooperative Oncology Group performance status, histologic type, tumor burden, presence of omental metastasis, and age (≤65 vs >65 years). In internal cross-validation, MERITS recommended PDS for 78.1% of patients and achieved a concordance index of 0.63. The current study will prospectively evaluate the clinical utility of feature-based selection and determine whether PDS improves overall survival in the selected population.

All participants must be recommended for PDS by MERITS and judged clinically suitable for both PDS and NACT-IDS. A 20-participant randomized pioneer study will first assess feasibility and early safety. Formal phase II enrollment may begin if major protocol deviations are observed in no more than 4 of 20 participants, 30-day grade ≥3 postoperative complications in no more than 6, 30-day postoperative deaths in no more than 1, at least 18 undergo the planned debulking procedure, and all operated participants have ascertainable 30-day safety outcomes.

The randomized phase II will enroll 100 participants. Phase II will be assessed after the 100th participant has completed 18 months of follow-up and surgical safety data have been verified. The phase II decision is exploratory and does not establish confirmatory noninferiority. The phase III will enroll 414 participants. The final phase III analysis will be performed after at least 247 deaths and at least 60 months of follow-up for the last phase III participant. Overall survival will be compared using a stratified log-rank test, with a stratified Cox model estimating the hazard ratio for PDS versus NACT-IDS and its two-sided 95% confidence interval. Stratification factors are TNM stage, cPCI tumor burden, and BRCA status. PDS will be considered superior only if the estimated hazard ratio is <1 and the two-sided stratified log-rank P value is <0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
534

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Zhongshan Hospital Fudan University
        • Contact:
        • Contact:
          • Libing Xiang, MD, PhD
          • Phone Number: 02164041990
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang cancer hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Low-grade ovarian carcinoma, mucinous ovarian carcinoma, or clear cell carcinoma.
  • Non-epithelial ovarian malignancy or borderline ovarian tumor.
  • 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.
  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary Debulking Surgery

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.
Procedure: Upfront cytoreductive surgery

Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

Drug: Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
Active Comparator: Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery

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.
Drug: Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

Procedure: Interval debulking surgery

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 60 months since randomization

Time from randomization to death from any cause; participants alive will be censored at the last date known alive.
60 months since randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 60 months since randomization

Time from randomization to first disease progression or death from any cause, whichever occurs first.
60 months since randomization
Postoperative complications within 30 days after surgery
Time Frame: Through 30 days after the planned debulking procedure

The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery, graded using CTCAE version 5.03
Through 30 days after the planned debulking procedure
Quality of life assessments
Time Frame: At baseline, 6 months, 12 months, and 5 years after randomization.

Quality of life measured with EORTC QLQ-C30
At baseline, 6 months, 12 months, and 5 years after randomization.
Pattern of first relapse
Time Frame: 60 months since randomization

The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
60 months since randomization
The rate of 3-year progression-free survival
Time Frame: 36 months since randomization

The rate of the patients without progression or recurrence or death at 3 years.
36 months since randomization
The rate of 5-year progression-free survival
Time Frame: 60 months since randomization

The rate of the patients without progression or recurrence or death at 5 years.
60 months since randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Gynecologic Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OV-AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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