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

Colorectal Cancer Clinical Trial

— proOMCRC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716257
• Other study ID #: 20201296
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: January 14, 2024

Study information

• Verified date: September 2021
• Source: West China Hospital
• Contact: Xiaofen Li, M.D.
• Phone: +86-28-85422589
• Email: lxf0827[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 14, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Ovarian Metastasis

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Cantón	Guangdong
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Changhai Hospital, Naval Medical University	Shanghai
China	Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute	Shenyang	Liaoning

Sponsors (4)

Lead Sponsor	Collaborator
West China Hospital	Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Changhai Hospital, Naval Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian specific overall survival	Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.	up to 3 years
Secondary	Ovarian specific objective response rate	Response rate of ovarian metastases to systemic chemotherapy	6 months
Secondary	Extra-ovarian specific objective response rate	Response rate of extra-ovarian metastases to systemic chemotherapy	6 months
Secondary	Progression free survival	Survival time from treatment start to disease progression or death.	6 months
Secondary	Quality of life questionnaire	Quality of life during treatment	6 months