Status:
RECRUITING
The ctDNA-RECIST Trial Part One
Lead Sponsor:
Karen-Lise Garm Spindler
Collaborating Sponsors:
Vejle Hospital
Conditions:
Gastrointestinal Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Detailed Description
Background: Circulating tumor DNA, (ctDNA) has the potential to better monitor treatment efficacy compared to imaging, possibly sparing the patient for ineffective treatment and their associated toxi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT06562348
Start Date
January 15 2025
End Date
September 1 2030
Last Update
May 1 2025
Active Locations (2)
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1
Aarhus University Hospital
Aarhus, Denmark, 8000
2
Department pf Oncology, Vejle Hospital
Vejle, Denmark, 7100