Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Recurrence occurred within 6 months since platinum-based chemotherapy;

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;

ECOG/WHO Performance score of 0 to 1;

Disqualifiers

Platinum-refractory/uncontrolled epithelial ovarian cancer;

Mucous carcinoma or low-grade serous carcinoma;

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

Patients have received abdominal or pelvic radiotherapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • cytoreductive surgery

    Other intervention

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: cytoreduction surgery followed by chemotherapyExperimental treatment 1 intervention
Group B: chemotherapy aloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

PFS

period from the end of treatment to the recurrence of disease

Time frame
month 6

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: