Actively Recruiting
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2022-11-07
400
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with first or second recurrence of epithelial ovarian, peritoneal, or fallopian tube carcinoma who had at least 4 cycles of platinum-based chemotherapy initially
- Relapse occurred more than 6 months after platinum-based chemotherapy
- Received PARP inhibitor maintenance therapy for more than 6 months before relapse
- Achieved complete tumor removal (R0) in initial surgery
- PET-CT shows isolated recurrence with no more than 5 lesions and ascites less than 500 ml
- ECOG/WHO Performance status of 0 to 1
- No liver failure; bilirubin ≤ 1.5 times normal, AST and ALT ≤ 3 times upper normal limit
- No kidney failure; serum creatinine < 1.5 times normal, creatinine clearance > 80 mL/min
- Adequate blood counts: neutrophils ≥ 1.5 x10^9/L, platelets ≥ 100 x10^9/L
- No contraindication to general anesthesia for major surgery
- Signed informed consent before any study procedures
You will not qualify if you...
- Platinum-refractory or uncontrolled epithelial ovarian cancer
- Non-epithelial ovarian tumors, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, or borderline tumors
- Other active cancers not in complete remission within the past 2 years
- Radiotherapy received within 2 weeks before study start
- General health condition unsuitable for secondary cytoreduction surgery
- Severe allergy (grade 3 or higher) to paclitaxel, platinum, or their components
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Trial Site Locations
Total: 1 location
1
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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