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Not yet recruiting NCT05633199

Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

No phase Interventional Cytoreductive Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cytoreductive surgery.
Who it may be relevant to
Registry conditions: Cytoreductive Surgery. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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,

Primary outcome measures

  • PFS [Time frame: month 6]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • General conditions cannot tolerate cytoreduction;
  • Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Women's Hospital, Zhejiang University School of Medicine — Hangzhou
  • Women's Hospital, Zhejiang University School of Medicine — Hangzhou

Publications

  • 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. PMID 37945326

Identifiers

NCT: NCT05633199 · CSPROC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗