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NCT05633199Not yet recruiting

Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer:a Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 1 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
140 (estimated)
First submitted
20 Nov 2022
Start date
1 Dec 2022
Primary completion date
1 Nov 2026
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
NCT number
NCT05633199

What you commit to

  • Study type: Interventional
  • Planned participants: 140
  • From 1 Dec 2022 to the primary completion date, 1 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients have received abdominal or pelvic radiotherapy;

Other illness

  • Platinum-refractory/uncontrolled epithelial ovarian cancer;
  • Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
  • General conditions cannot tolerate cytoreduction;
  • Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;

Other

  • Mucous carcinoma or low-grade serous carcinoma;
  • Unable or unwilling to sign the informed consent form;
  • Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.

Who the study is looking for

  • 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;
  • Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
  • No Renal insufficiency: serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 60 mL/min;
  • No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
  • Patients with good compliance;
  • Patients having read, signed and dated Informed consent before any study procedure.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Women's Hospital, Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.