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Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05633199
Collaborator
(none)
140
Enrollment
2
Locations
2
Arms
61
Anticipated Duration (Months)
70
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cytoreductive surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: cytoreduction surgery followed by chemotherapy

Other: 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.
No Intervention: chemotherapy alone

Outcome Measures

Primary Outcome Measures

  1. PFS [month 6]

    period from the end of treatment to the recurrence of disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Hospital, Zhejiang University School of Medicine Hangzhou China
2 Women's Hospital, Zhejiang University School of Medicine Hangzhou China

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT05633199
Other Study ID Numbers:
  • CSPROC
First Posted:
Dec 1, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 1, 2022