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NCT Number: NCT07263178

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

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.

Recruiting

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Seung Tae Kim, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to 24 months

    Progression-free survival (PFS) by treatment pattern

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to 24 months

    Overall Survival (OS) by treatment pattern

  2. Dosage period for each treatment pattern

    Time frame: up to 24 months

  3. Objective Response Rate (ORR)

    Time frame: up to 24 months

  4. Types of Secondary palliative chemotherapy

    Time frame: up to 24 months

  5. Types of Third palliative chemotherapy

    Time frame: up to 24 months

  6. Conversion rate

    Time frame: up to 24 months

    Conversion rate to resectable group by treatment pattern

  7. 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).

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

027088000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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