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Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05633199
Recruitment Status : Not yet recruiting
First Posted : December 1, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Women's Hospital School Of Medicine Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cytoreductive Surgery Other: cytoreductive surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer:a Randomized Controlled Study
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : January 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: cytoreduction surgery followed by chemotherapy 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, at least for 4 cycles.

No Intervention: chemotherapy alone



Primary Outcome Measures :
  1. PFS [ Time Frame: month 6 ]
    period from the end of treatment to the recurrence of disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633199


Locations
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China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, China
Contact: Junfen Xu, Dr    0086-13567147767    xjfzu@zju.edu.cn   
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, China
Contact: Junfen Xu    0086-13567147767    xjfzu@zju.edu.cn   
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
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Responsible Party: Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT05633199    
Other Study ID Numbers: CSPROC
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No