Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

NCT ID: NCT05633199

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2028-01-01

Brief Summary

This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.

Conditions

Cytoreductive Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cytoreduction surgery followed by chemotherapy

Group Type: EXPERIMENTAL

cytoreductive surgery

Intervention Type: OTHER

Open surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery, at least for 4 cycles.

chemotherapy alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cytoreductive surgery

Open surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery, at least for 4 cycles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;

2. Recurrence occurred within 6 months since platinum-based chemotherapy;

3. R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;

4. ECOG/WHO Performance score of 0 to 1;

5. Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;

6. No Renal insufficiency: serum creatinine < 1,5 time the normal limit, creatinine clearance > 60 mL/min;

7. No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;

8. Patients with good compliance;

9. Patients having read, signed and dated Informed consent before any study procedure.

Exclusion Criteria

1. Platinum-refractory/uncontrolled epithelial ovarian cancer;

2. Mucous carcinoma or low-grade serous carcinoma;

3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;

4. Patients have received abdominal or pelvic radiotherapy;

5. General conditions cannot tolerate cytoreduction;

6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;

7. Unable or unwilling to sign the informed consent form;

8. Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.

• 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, , China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Countries

China

Facility Contacts

Junfen Xu, Dr

Role: primary

xjfzu@zju.edu.cn

0086-13567147767

Junfen Xu

Role: primary

xjfzu@zju.edu.cn

0086-13567147767

References

Chen T, Xu J, Xia B, Wang H, Shen Y. Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study. J Gynecol Oncol. 2024 Jan;35(1):e22. doi: 10.3802/jgo.2024.35.e22. Epub 2023 Oct 30.

Reference Type: DERIVED

PMID: 37945326 (View on PubMed)

Other Identifiers

CSPROC

Identifier Type: -

Identifier Source: org_study_id