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

November 23, 2025 updated by: Boryung Pharmaceutical Co., Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Seung Tae Kim, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: up to 24 months
Progression-free survival (PFS) by treatment pattern
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 24 months
up to 24 months
Overall Survival (OS)
Time Frame: up to 24 months
Overall Survival (OS) by treatment pattern
up to 24 months
Dosage period for each treatment pattern
Time Frame: up to 24 months
up to 24 months
Types of Secondary palliative chemotherapy
Time Frame: up to 24 months
up to 24 months
Types of Third palliative chemotherapy
Time Frame: up to 24 months
up to 24 months
Conversion rate
Time Frame: up to 24 months
Conversion rate to resectable group by treatment pattern
up to 24 months
Quality of Life Assessment
Time Frame: up to 12 months
The FACT-C (Functional Assessment of Cancer Therapy-Colorectal) questionnaire uses a 5-point Likert-type scale. The responses generally range from 0 (Not at all) to 4 (Very much).
up to 12 months
Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment
Time Frame: up to 24 months
The ECOG PS uses a scale from 0 to 5, where a score of 5 specifically means the patient is deceased. The score of 0 indicates the best performance status (fully active), while 4 indicates the worst performance status for a living patient (completely disabled/bedridden).
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-CPT-OS-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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