NCT05633199

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2022Jan 2028

First Submitted

Initial submission to the registry

November 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

November 20, 2022

Last Update Submit

November 30, 2022

Conditions

Cytoreductive Surgery

Outcome Measures

Primary Outcomes (1)

  • PFS

    period from the end of treatment to the recurrence of disease

    month 6

Study Arms (2)

cytoreduction surgery followed by chemotherapy

EXPERIMENTAL
Other: cytoreductive surgery

chemotherapy alone

NO INTERVENTION

Interventions

cytoreductive surgeryOTHER

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.

cytoreduction surgery followed by chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Related Publications (1)

  • 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: 37945326DERIVED

MeSH Terms

Interventions

Cytoreduction Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2022

First Posted

December 1, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

December 1, 2022

Record last verified: 2022-11

Locations

CN(2)