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RECRUITING
NCT06208371
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2024-01-15

Completion Date

2029-06-30

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

PROCEDURE

Surgical resection and/or ablation therapy and/or SBRT

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

DRUG

Palliative 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.

Locations (1)

Sun Yat-sen Cancer Center

Guangzhou, Guangdong, China