To hear about similar clinical trials, please enter your email below
Trial 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
NCT ID:
NCT05607329
Condition:
Relapsed Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Secondary cytoreduction
Description:
Open surgery is conducted by senior clinicians in gynecological oncology. Operation
time，location and number of relapsed lesions, location and number of excised lesions,
Whether achieved R0 or not, and other information are recorded.
Arm group label:
Secondary cytoreduction followed by chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
chemotherapy
Arm group label:
Secondary cytoreduction followed by chemotherapy
Arm group label:
chemotherapy alone
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanming Shen, Dr
Phone:
0086-13588193832
Email:
11318160@zju.edu.cn
Start date:
May 1, 2021
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05607329
