The ctDNA-RECIST Trial Part One

NCT06562348 · tracked via the Priya Life Science Denmark tracker

Sponsor

Karen-Lise Garm Spindler

Phase

Phase 2

Started

2025-01-15

Last updated

2025-05-01

Condition(s) studied

Gastrointestinal Neoplasm

Investigational drug(s) / intervention(s)

Standard of carectDNA-RECIST guided palliative systemic treatment

Standard of care: 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.

ctDNA-RECIST guided palliative systemic treatment: 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.

Study summary

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Compliance with protocol — 3 months
The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion.

Trial sites (2)

Facility	City	Region	Status
Aarhus University Hospital	Aarhus	Denmark	Recruiting
Department pf Oncology, Vejle Hospital	Vejle	Denmark	Recruiting

More Karen-Lise Garm Spindler trials in Denmark

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06562348 on ClinicalTrials.gov ↗ ← All trials in Denmark