A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.

NCT07263178 | Recruiting

• 1 other identifier: BR-CPT-OS-402
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to comprehensively identify the various treatment patterns of second- or subsequent-line palliative chemotherapy used in patients with metastatic colorectal cancer who have experienced failure of first-line palliative chemotherapy and to evaluate the prognosis of each treatment.

Conditions

Metastatic Colorectal Cancer

Keywords

Palliative chemotherapy; Metastatic Colorectal Cancer; Observation Study

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) by treatment pattern

  up to 24 months

Secondary Outcomes (8)

• Overall Survival (OS)

  up to 24 months

• Dosage period for each treatment pattern

  up to 24 months

• Objective Response Rate (ORR)

  up to 24 months

• Types of Secondary palliative chemotherapy

  up to 24 months

• Types of Third palliative chemotherapy

  up to 24 months

Interventions

Second and later-line palliative chemotherapy DRUG

As this is a non-interventional study designed to collect data as part of routine clinical practice, the selection and dosage of medication, treatment period, and whether or not to change it are all based on the clinician's judgment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer (colon and rectal cancer) who have failed first-line palliative chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Shinyoung Oh

CONTACT

027088000; syoh@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

KR (1)