Clinical trial · Interventional
The ctDNA-RECIST Trial Part One
ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
NCT06562348CI-TRIAL-00089206ctDNA-RECISTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasm | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA-RECIST guided palliative systemic treatment | Other | — | UNRESOLVED |
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Standard of care
- description
- Response evaluation using imaging-based RECIST according to standard guidelines.
- interventionNames
- Other: Standard of care
- type
- EXPERIMENTAL
- label
- ctDNA-RECIST guided therapy approach
- description
- Response evaluation will be performed using ctDNA-RECIST instead of imaging.
- interventionNames
- Other: ctDNA-RECIST guided palliative systemic treatment
Primary outcomes (1)
- measure
- Compliance with protocol
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.