RecruitingPhase 3NCT06208371

Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM

The DECIDE-CRLM-10 Randomized Controlled Study: Comparison of Chemotherapy Combined With Localized Treatment for Liver Metastases Versus Palliative Chemotherapy Alone in Colorectal Patients With 10 or More Liver Metastases

Sponsor

Sun Yat-sen University

Enrollment

117 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Malignant

Summary

The goal of this clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. We aim to answer the following question: Can localized interventions, including surgery and/or ablation and/or stereotactic body radiotherapy (SBRT), enhance the 5-year survival rate compared to palliative chemotherapy alone in patients with ≥10 colorectal liver metastases (CRLM)? Participants in this study, who have achieved disease control through chemotherapy, will undergo either localized interventions (surgery and/or ablation and/or SBRT) or receive palliative chemotherapy alone. Researchers will compare the survival outcomes between these groups to determine the potential benefits of localized interventions for patients with ≥10 CRLM.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for colorectal cancer patients who have 10 or more liver metastases: aggressive local treatments (such as surgery, ablation, or radiation) versus continuing chemotherapy alone. Researchers want to find out if directly treating the liver tumors can extend survival in these complex cases. **You may be eligible if...** - You are 18 or older with biopsy-confirmed colorectal cancer and 10 or more liver metastases - Your cancer has not spread outside the liver (or only has tiny, uncertain lung/lymph node spots) - Your liver disease showed control (stable or partial response) after at least 8 cycles of chemotherapy **You may NOT be eligible if...** - Your cancer has confirmed spread to other organs beyond the liver - Your liver tumors progressed on chemotherapy - You are not healthy enough to tolerate local treatment procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESurgical resection and/or ablation therapy and/or SBRT

Participants may receive surgical resection and/or ablation therapy and/or stereotactic body radiotherapy

DRUGPalliative Chemotherapy

Participants in this group may continue the original systemic chemotherapy regimen. Patients with tumor control after 10-12 cycles can either transition to maintenance treatment or temporarily suspend treatment until disease progression, at which point they switch to a second-line treatment regimen.The selection of second-line and subsequent treatment regimens follows CSCO guidelines and clinical practices.