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Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial

Primary Purpose

Relapsed Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Secondary cytoreduction
Chemotherapy
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Ovarian Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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; 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 the ascites 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 the Upper Normal Limit No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 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 Criteria: Platinum-refractory/uncontrolled epithelial ovarian cancer; Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor; Suffering from other malignant tumors that have not achieved complete remission in the past 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 of its excipients.

Sites / Locations

  • Women's Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Secondary cytoreduction followed by chemotherapy

chemotherapy alone

Arm Description

Outcomes

Primary Outcome Measures

progression free survival (PFS)
progression free survival

Secondary Outcome Measures

Full Information

First Posted
November 2, 2022
Last Updated
November 4, 2022
Sponsor
Women's Hospital School Of Medicine Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05607329
Brief 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
Official Title
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Secondary cytoreduction followed by chemotherapy
Arm Type
Experimental
Arm Title
chemotherapy alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Secondary cytoreduction
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
chemotherapy
Primary Outcome Measure Information:
Title
progression free survival (PFS)
Description
progression free survival
Time Frame
18-24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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 the ascites 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 the Upper Normal Limit No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 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 Criteria: Platinum-refractory/uncontrolled epithelial ovarian cancer; Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor; Suffering from other malignant tumors that have not achieved complete remission in the past 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 of its excipients.
Facility Information:
Facility Name
Women's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanming Shen, Dr
Phone
0086-13588193832
Email
11318160@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial

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