NCT07263178RecruitingNot Applicable
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
Boryung Pharmaceutical Co., Ltd1 site in 1 country1,000 target enrollmentStarted: November 7, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: up to 24 months
Progression-free survival (PFS) by treatment pattern
Secondary Outcomes
- Objective Response Rate (ORR)(up to 24 months)
- Types of Third palliative chemotherapy(up to 24 months)
- Conversion rate(up to 24 months)
- Quality of Life Assessment(up to 12 months)
- Overall Survival (OS)(up to 24 months)
- Dosage period for each treatment pattern(up to 24 months)
- Types of Secondary palliative chemotherapy(up to 24 months)
- Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment(up to 24 months)
Investigators
Study Sites (1)
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