Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach for women with platinum-resistant recurrent ovarian cancer. Specifically, it aims to find out if having cytoreductive surgery (a type of surgery that removes as much of the cancer as possible) followed by chemotherapy works better than chemotherapy alone for patients whose cancer has returned within six months after their last platinum-based treatment. The goal is to see if this combination can improve patients' outcomes and overall health.

To participate in this trial, women aged 65 to 75 who have been diagnosed with certain types of ovarian cancer may be eligible, as long as their cancer has returned within six months after treatment with platinum drugs. They also need to meet specific health criteria, such as having good blood cell counts and no severe kidney or liver issues. If eligible, participants can expect to undergo the surgery and follow-up with chemotherapy, and they will receive guidance and support throughout the process. It's important for potential participants to understand all the study details and provide their consent before joining.

Gender

FEMALE

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.