NCT05607329 Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
| NCT ID | NCT05607329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Condition | Relapsed Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2021-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.
Eligibility Criteria
Inclusion Criteria: 1. Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment; 2. Relapse occurred after 6 month since platinum-based chemotherapy; 3. PARPi maintenance therapy for more than 6 months before relapse; 4. R0 ideal debulking in initial surgery; 5. PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml; 6. ECOG/WHO Performance score of 0 to 1; 7. No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit 8. No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method 9. Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L 10. No contraindication to general anaesthesia for heavy surgery 11. Patients having read, signed and dated Informed consent before any study procedure Exclusion Criteria: 1. Platinum-refractory/uncontrolled epithelial ovarian cancer; 2. Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor; 3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years; 4. Received radiotherapy within 2 weeks before the start of the study intervention; 5. General conditions cannot tolerate secondary cytoreduction; 6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.
Frequently Asked Questions
Who can join the NCT05607329 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Relapsed Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05607329 currently recruiting?
Yes, NCT05607329 is actively recruiting participants. Visit ClinicalTrials.gov or contact Women's Hospital School Of Medicine Zhejiang University to inquire about joining.
Where is the NCT05607329 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05607329 clinical trial?
NCT05607329 is sponsored by Women's Hospital School Of Medicine Zhejiang University. The trial plans to enroll 400 participants.
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