Using ctDNA to guide treatment for metastatic gastrointestinal cancer
ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
PHASE2 · Aarhus University Hospital · NCT06562348
This study is testing if using blood tests to check for tumor DNA can help doctors make better treatment choices for people with advanced gastrointestinal cancer compared to regular imaging methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 167 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT06562348 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates whether analyzing circulating tumor DNA (ctDNA) can improve treatment decisions for patients with metastatic gastrointestinal cancers compared to traditional imaging methods. Patients are randomly assigned to receive either standard treatment evaluated by imaging or treatment guided by ctDNA response criteria. The ctDNA-RECIST criteria aim to provide a more accurate assessment of treatment efficacy, potentially allowing for timely adjustments to therapy. The study seeks to determine if ctDNA can better monitor treatment responses and reduce unnecessary toxicities.
Who should consider this trial
Good fit: Ideal candidates include adults with incurable metastatic gastrointestinal cancer who are eligible for first or second-line systemic treatment.
Not a fit: Patients with significant comorbidities or concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with gastrointestinal cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for treatment monitoring, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Incurable metastatic gastrointestinal cancer * Indication for first or second-line systemic treatment * Measurable disease according to RECIST v.1.1 * CT of chest and abdomen less than 30 days old at time of treatment initiation * Age at least 18 years * ECOG performance status 0-2 * Clinically eligible systemic palliative treatment at investigators decision. * Adequate bone marrow, liver and renal function allowing systemic chemotherapy * Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * Written and verbally informed consent Exclusion Criteria: * Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy * Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri * Pregnant (positive pregnancy test) or breast-feeding women
Where this trial is running
Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
- Department pf Oncology, Vejle Hospital — Vejle, Denmark (RECRUITING)
Study contacts
- Principal investigator: Karen-Lise G Spindler, MD, Prof — Department of Oncology, Aarhus University Hospital
- Study coordinator: Karen-Lise G Spindler, MD, Prof
- Email: k.g.spindler@rm.dk
- Phone: +4591167244
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.
Conditions: Gastrointestinal Neoplasm, Circulating Tumor DNA, Liquid Biopsy, Metastatic