Clinical trial · Interventional
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer:a Randomized Controlled Study
NCT05633199CI-TRIAL-00062432not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytoreductive Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytoreductive surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cytoreduction surgery followed by chemotherapy
- interventionNames
- Other: cytoreductive surgery
- type
- NO_INTERVENTION
- label
- chemotherapy alone
Primary outcomes (1)
- measure
- PFS
- timeFrame
- month 6
- description
- period from the end of treatment to the recurrence of disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChen 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