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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04716257
Acronym
proOMCRC
Enrollment
400
Registered
2021-01-20
Start date
2021-01-14
Completion date
2025-09-14
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Ovarian Metastasis

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.

Interventions

None listed

Sponsors

Sun Yat-sen University
CollaboratorOTHER
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
CollaboratorUNKNOWN
Changhai Hospital, Naval Medical University
CollaboratorUNKNOWN
West China Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ovarian specific overall survivalup to 3 yearsCalculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.

Secondary

MeasureTime frameDescription
Ovarian specific objective response rate6 monthsResponse rate of ovarian metastases to systemic chemotherapy
Extra-ovarian specific objective response rate6 monthsResponse rate of extra-ovarian metastases to systemic chemotherapy
Progression free survival6 monthsSurvival time from treatment start to disease progression or death.
Quality of life questionnaire6 monthsQuality of life during treatment

Countries

China

Contacts

Primary ContactMeng Qiu, M.D.
hxqmtg@163.com+86-28-85422589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026