Comparing localized treatment to palliative chemotherapy for colorectal cancer patients with multiple liver metastases
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
This study is testing if localized treatments like surgery or radiation can help colorectal cancer patients with multiple liver tumors live longer compared to just using palliative chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06208371 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether localized interventions, such as surgery, ablation, or stereotactic body radiotherapy (SBRT), can improve the 5-year survival rate for colorectal cancer patients with 10 or more liver metastases compared to palliative chemotherapy alone. Participants who have achieved disease control through chemotherapy will be randomized to receive either localized treatment or continue with palliative chemotherapy. The study aims to determine the effectiveness of these localized interventions in enhancing survival outcomes for patients with colorectal liver metastases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed colorectal adenocarcinoma and at least 10 liver metastases who have achieved disease control after chemotherapy.
Not a fit: Patients with extrahepatic metastases or those who do not meet the criteria for localized interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option that significantly improves survival rates for patients with colorectal cancer and multiple liver metastases.
How similar studies have performed: Previous studies have shown promising results for localized treatments in colorectal liver metastases, suggesting potential benefits, although this specific approach is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed colorectal adenocarcinoma. * Baseline imaging (CT, MRI, or PET/CT as necessary) or pathological confirmation of liver metastasis, with no extrahepatic metastasis (consideration for inclusion may be given to lesions with a diameter less than 10mm in the lungs or lymph nodes if metastasis is difficult to confirm or is suspected). * Disease control (PR or SD) achieved after a minimum of 8 cycles of systemic chemotherapy. * Evaluation by a centralized liver surgeon expert group to confirm presence of ≥10 liver metastases, which can be managed through surgery and/or ablation and/or SBRT to achieve NED. Non-resectability is defined as one or more of the following: ① Unable to undergo R0 resection; ② Predicted insufficient remaining liver volume after resection; ③ After resection, none of the three hepatic veins can be preserved, and the preservation of residual liver inflow and outflow and bile ducts cannot be guaranteed, and adjacent two liver segments cannot be preserved. * Curative surgery possible for the primary colorectal lesion. * Normal hematological, hepatic, and renal functions at baseline. * Child-Pugh grade A liver function. * ECOG performance status 0-1. * Tolerability to undergo further surgery and chemotherapy. * Life expectancy \> 3 months. * Signed written informed consent. * Willing and able to undergo follow-up until death, study completion, or study termination. Exclusion Criteria: * Definite presence of extrahepatic metastasis and/or primary tumor not amenable to curative surgical resection. * Severe arterial embolism or ascites. * Bleeding tendencies or coagulation disorders. * Hypertensive crisis or hypertensive encephalopathy. * Severe uncontrollable systemic complications such as infection or diabetes. * Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension despite appropriate medical treatment, unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiring medication. * History or physical examination indicating central nervous system diseases (such as primary brain tumor, uncontrollable epilepsy, any brain metastasis, or history of stroke). * Diagnosis of other malignant tumors within the past 5 years (excluding basal cell carcinoma after radical surgery and/or cervical carcinoma in situ). * Pregnant or lactating women. * Women of childbearing potential not using or refusing to use effective non-hormonal contraceptive methods (intrauterine devices, combined barrier contraceptive methods with spermicidal gel, or sterilization) or men with reproductive potential. * Inability or unwillingness to comply with the study protocol. * Any other diseases, metastatic lesions causing functional impairment, or suspicious findings in the physical examination indicating possible contraindications for the use of investigational drugs or placing the patient at a high risk of treatment-related complications.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yuhong Li, PhD
- Email: liyh@sysucc.org.cn
- Phone: 87342487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.