The ctDNA-RECIST Trial Part One
ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
Karen-Lise Garm Spindler
167 participants
Jan 15, 2025
INTERVENTIONAL
Conditions
Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Eligibility
Inclusion Criteria10
- 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 Criteria3
- 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
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Interventions
Patients will be offered palliative systemic treatment according to standard of care. Response evaluation will be performed with the imaging-based RECIST according to standard guidelines. Treatment pauses according to institutional guidelines. Blood samples will be analyzed retrospectively to evaluate ctDNA.
Patients are offered palliative systemic treatment according to standard of care. Response evaluation will be performed using ctDNA-RECIST. ctDNA is measured before start of treatment. If the baseline sample is ctDNA negative the patient is transferred to an observational cohort, and sampling procedures continues as in the standard arm. If the baseline sample is ctDNA positive the patient continues in the ctDNA-RECIST guided arm. Treatment response is evaluated according to ctDNA-RECIST, and further sampling follows a predefined decision schedule.
Locations(2)
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NCT06562348