Comparing secondary surgery plus chemotherapy to chemotherapy alone for relapsed ovarian cancer after PARPi treatment
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial
This study is testing whether adding surgery to chemotherapy helps women with relapsed ovarian cancer feel better compared to just getting chemotherapy alone after they've been on a specific treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05607329 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of secondary cytoreduction followed by chemotherapy compared to chemotherapy alone in patients with relapsed ovarian cancer who have undergone PARPi maintenance treatment. It is a multicenter, randomized controlled trial that aims to analyze the clinicopathological and molecular characteristics of these patients. The study will assess whether patients who have been on PARPi maintenance for over six months are sensitive to platinum-based drugs and the potential benefits of secondary tumor cell reduction. The goal is to provide evidence-based recommendations for treating recurrent ovarian cancer after PARPi maintenance.
Who should consider this trial
Good fit: Ideal candidates include patients with first-line or second-line recurrent epithelial ovarian, peritoneal, or fallopian tube carcinoma who have undergone PARPi maintenance therapy for more than six months.
Not a fit: Patients who have not received prior platinum-based chemotherapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with relapsed ovarian cancer, potentially enhancing survival rates and quality of life.
How similar studies have performed: Other studies have shown promise in similar approaches, but this specific combination of secondary cytoreduction and chemotherapy in the context of PARPi maintenance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.