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

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2028-05-01

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.

Conditions

Relapsed Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secondary cytoreduction followed by chemotherapy

Group Type: EXPERIMENTAL

Secondary cytoreduction

Intervention Type: PROCEDURE

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.

Chemotherapy

Intervention Type: DRUG

chemotherapy

chemotherapy alone

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

chemotherapy

Interventions

Secondary cytoreduction

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: PROCEDURE

Chemotherapy

chemotherapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuanming Shen, Dr

Role: primary

11318160@zju.edu.cn

0086-13588193832

References

Chen T, Xu J, Xia B, Wang H, Shen Y. Secondary cytoreduction surgery for recurrent epithelial ovarian cancer patients after PARPi maintenance: A multicenter, randomized, controlled clinical trial. Int J Gynecol Cancer. 2024 Feb 5;34(2):328-331. doi: 10.1136/ijgc-2023-004978.

Reference Type: DERIVED

PMID: 38159938 (View on PubMed)

Other Identifiers

SCAP-3

Identifier Type: -

Identifier Source: org_study_id