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
Surgical resection and/or ablation therapy and/or SBRT
+ Palliative Chemotherapy
Colonic Diseases+8
+ Colonic Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: January 15, 2024
Actual date on which the first participant was enrolled.This clinical trial is exploring treatment options for patients who have colorectal cancer with at least 10 liver metastases. Colorectal cancer often spreads to the liver, and when this happens, it can be challenging to treat effectively. While surgery is a common way to remove cancer from the liver, only a small percentage of patients qualify for such procedures. This study aims to determine if combining surgery or other localized treatments with chemotherapy can improve survival rates over chemotherapy alone for patients who have many liver metastases. This research is important because it might offer new hope and better outcomes for patients who currently have limited treatment options. Participants in the study will first receive chemotherapy to control the cancer in their liver. After achieving disease control, they will be randomly assigned to receive either additional localized treatment, such as surgery, ablation, or stereotactic body radiotherapy (SBRT), or continue with chemotherapy alone. The study will monitor the participants over five years to see if those who receive the localized treatments live longer than those who only receive chemotherapy. This trial hopes to provide new evidence on the effectiveness of combining local interventions with chemotherapy in improving survival rates in patients with numerous liver metastases.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.117 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location