A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Second and later-line palliative chemotherapy.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Second and later-line palliative chemotherapy
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
Primary outcome measures
- Progression-free survival (PFS) [Time frame: up to 24 months]
Secondary outcome measures (8)
- Overall Survival (OS) [Time frame: up to 24 months]
- Dosage period for each treatment pattern [Time frame: up to 24 months]
- Objective Response Rate (ORR) [Time frame: up to 24 months]
- Types of Secondary palliative chemotherapy [Time frame: up to 24 months]
- Types of Third palliative chemotherapy [Time frame: up to 24 months]
- Conversion rate [Time frame: up to 24 months]
- Quality of Life Assessment [Time frame: up to 12 months]
- Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment [Time frame: up to 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07263178 · BR-CPT-OS-402