ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 167
- Locations
- 2
- Primary Endpoint
- Compliance with protocol
Study Overview
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 toxicity an allowing for an early change of the treatment approach.
Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria.
Aim: This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors (ctDNA-RECIST) versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers.
Design: Patients are randomized 1:1. Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging, and treatment pauses according to institutional guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A: Standard of care
Response evaluation using imaging-based RECIST according to standard guidelines.
Intervention: Standard of care (Other)
ctDNA-RECIST guided therapy approach
Response evaluation will be performed using ctDNA-RECIST instead of imaging.
Intervention: ctDNA-RECIST guided palliative systemic treatment (Other)
Outcomes
Primary Outcomes
Compliance with protocol
Time Frame: 3 months
The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion.
Secondary Outcomes
- Number of treatment cycles(1 year)
- Response rate Arm A(1 year)
- ctDNA response rate Arm B(1 year)
Investigators
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital