Metastatic Colorectal Cancer
Conditions
Keywords
Palliative chemotherapy, Metastatic Colorectal Cancer, Observation Study
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.
Interventions
DRUGSecond 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
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 24 months | Progression-free survival (PFS) by treatment pattern |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Overall Survival (OS) | up to 24 months | Overall Survival (OS) by treatment pattern |
| Conversion rate | up to 24 months | Conversion rate to resectable group by treatment pattern |
| Quality of Life Assessment | 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). |
| Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment | 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). |
| Types of Third palliative chemotherapy | up to 24 months | — |
Countries
South Korea
Contacts
Primary ContactShinyoung Oh
Outcome results
None listed