ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial

What this Trial Is About

Researchers are evaluating whether analyzing circulating tumor DNA (ctDNA) can better guide palliative treatment decisions in patients with metastatic gastrointestinal cancer compared to the standard imaging method called RECIST. This phase II randomized trial aims to see if using ctDNA-RECIST criteria to assess treatment response can improve monitoring and potentially reduce ineffective treatments and their side effects. Participants are randomly assigned to one of two groups. One group receives standard palliative systemic treatment with response evaluations based on imaging scans using RECIST criteria, following institutional guidelines for treatment pauses. The other group receives similar treatment but with response evaluations guided by ctDNA changes measured in blood samples. If ctDNA is undetectable at baseline, patients are observed similarly to the standard group. Those with detectable ctDNA have treatment responses assessed by ctDNA-RECIST criteria, including categories like progressive disease, stable disease, partial response, and complete or near complete response. During the study, participants undergo regular blood sampling and imaging scans to monitor disease status and treatment responses. The primary outcome is compliance with the protocol over three months. Secondary outcomes include the number of treatment cycles and response rates in each group over one year. The study evaluates whether ctDNA can be used effectively to guide treatment decisions in this patient population, with ongoing safety and treatment monitoring throughout the trial.

The ctDNA-RECIST Trial Part One