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Clinical Trials/NCT04716257
NCT04716257
Recruiting
Not Applicable

Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study

West China Hospital4 sites in 1 country400 target enrollmentJanuary 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Metastasis
Sponsor
West China Hospital
Enrollment
400
Locations
4
Primary Endpoint
Ovarian specific overall survival
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

Detailed Description

This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.

Registry
clinicaltrials.gov
Start Date
January 14, 2021
End Date
September 14, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meng Qiu

Prof.

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed colorectal adenocarcinoma;
  • Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
  • Women ≥18 years of age;
  • Eastern Cooperative Oncology Group performance status score ≤2;
  • Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
  • Complete medical records;
  • Informed consent form signed.

Exclusion Criteria

  • Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
  • Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
  • Other conditions that would influence patient compliance;
  • Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.

Outcomes

Primary Outcomes

Ovarian specific overall survival

Time Frame: up to 3 years

Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.

Secondary Outcomes

  • Ovarian specific objective response rate(6 months)
  • Quality of life questionnaire(6 months)
  • Extra-ovarian specific objective response rate(6 months)
  • Progression free survival(6 months)

Study Sites (4)

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