Using ctDNA to guide treatment for metastatic gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.