Second- and later-line palliative chemotherapy options for metastatic colorectal cancer.

A Multi-center, Prospective, Observational Study to Assess the Treatment Patterns and Prognosis of Second and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer Who Failed First-line Palliative Chemotherapy

This study will see how different second- or later-line palliative chemotherapy treatments are used and what outcomes patients with metastatic colorectal cancer have after first-line chemotherapy stops working.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Boryung Pharmaceutical Co., Ltd (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Seoul)
• Trial ID: NCT07263178 on ClinicalTrials.gov

What this trial studies

This is an observational study enrolling patients with histologically and radiologically confirmed metastatic colorectal cancer who are starting their first second-line palliative chemotherapy after failure of first-line treatment. Investigators will record the specific chemotherapy regimens, dosing, timing, and any supportive treatments, and will track tumor responses, progression, survival, and adverse events over time. The goal is to describe real-world treatment patterns and compare prognosis across the commonly used second- and later-line regimens. The study is conducted at Samsung Medical Center and sponsored by Boryung Pharmaceutical Co., Ltd.

Who should consider this trial

Good fit: Adults with measurable metastatic colorectal cancer who have failed first-line palliative chemotherapy and are about to begin their first second-line palliative chemotherapy and who can provide informed consent are ideal candidates.

Not a fit: Patients looking for experimental investigational treatments, those who are pregnant or breastfeeding, or those unable to attend visits at the Seoul study site are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, results could help doctors choose second-line palliative chemotherapy regimens that are associated with better outcomes and set clearer expectations for patients.

How similar studies have performed: Similar observational analyses of real-world treatment patterns in metastatic colorectal cancer have been performed and have informed clinical practice, so this approach is established rather than novel.

Eligibility criteria

Inclusion Criteria:

* Patients who have signed the informed consent after receiving information about the purpose and method of this study.
* Patients with histologically and radiologically confirmed metastatic colorectal cancer (colorectal cancer) who have evaluable (measurable) lesions.
* Patients scheduled to receive their first second-line palliative chemotherapy following failure of first-line palliative chemotherapy (including those who relapse during or within 6 months after completion of postoperative adjuvant therapy, necessitating palliative chemotherapy).
* Patients who understand the research, are cooperative in the research process, and are deemed capable of participating until the completion date.

Exclusion Criteria:

* Female patients who are pregnant, have childbearing potential, or are breastfeeding.
* Has received an investigational product within 4 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study.
* Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Shinyoung Oh

Conditions: Metastatic Colorectal Cancer, Palliative chemotherapy, Observation Study