Last updated: November 4, 2022
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Ovarian Cysts
Recurrent Ovarian Cancer
Treatment
N/AClinical Study ID
NCT05607329
SCAP-3
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with diagnosis of first-line or second-line recurrent epithelial ovariancarcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previouslyreceived at least 4 cycles of platinum-based chemotherapy in initial treatment;
- Relapse occurred after 6 month since platinum-based chemotherapy;
- PARPi maintenance therapy for more than 6 months before relapse;
- R0 ideal debulking in initial surgery;
- PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and theascites is less than 500ml;
- ECOG/WHO Performance score of 0 to 1;
- No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time theUpper Normal Limit
- No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinineclearance > 80 mL/min). calculated with MDRD method
- Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
- No contraindication to general anaesthesia for heavy surgery
- Patients having read, signed and dated Informed consent before any study procedure
Exclusion
Exclusion Criteria:
- Platinum-refractory/uncontrolled epithelial ovarian cancer;
- Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignantBrenner tumor, low-grade serous carcinoma, borderline tumor;
- Suffering from other malignant tumors that have not achieved complete remission in thepast 2 years;
- Received radiotherapy within 2 weeks before the start of the study intervention;
- General conditions cannot tolerate secondary cytoreduction;
- Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any ofits excipients.
Study Design
Total Participants: 400
Study Start date:
May 01, 2021
Estimated Completion Date:
May 01, 2028
Connect with a study center
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting

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