A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients

Recruiting

• Conditions: Colorectal Cancer; Ovarian Metastasis

• Registration Number: NCT04716257
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-09-14
• Study Completion: 2025-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian specific overall survival	up to 3 years	Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.

Secondary Outcome Measures

Name	Time	Method
Ovarian specific objective response rate	6 months	Response rate of ovarian metastases to systemic chemotherapy
Quality of life questionnaire	6 months	Quality of life during treatment
Extra-ovarian specific objective response rate	6 months	Response rate of extra-ovarian metastases to systemic chemotherapy
Progression free survival	6 months	Survival time from treatment start to disease progression or death.

Trial Locations

Locations (4)

Sun Yat-sen University Cancer Center; 🇨🇳 Cantón, Guangdong, China

Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute; 🇨🇳 Shenyang, Liaoning, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Changhai Hospital, Naval Medical University; 🇨🇳 Shanghai, China