Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
167 participants
INTERVENTIONAL
2025-01-15
2030-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)
NCT02443948
ctDNA for Early Detection of Recurrence in Melanoma
NCT06246227
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
NCT04354064
Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)
NCT05736523
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
NCT04576858
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
In Arm B, treatment response is evaluated based on change in ctDNA between the baseline sample and the evaluation and confirmation sample, according to ctDNA-RECIST:
* Progressive disease: An increase of ctDNA above the previous value with no overlap of the two CI's
* Stable disease: A value within CI of the previous value. The category also includes samples with both previous and present value being 0 (undetectable).
* Partial Response: A decrease below the previous value with no overlap of the two CI'S but the lower CI does not overlap 0.
* Complete response: Decreasing value to an undetectable level
* Near complete response: A decrease below the previous value with no overlap of the two CI'S and with the lower CI overlapping 0
Complete and near complete response can be combined and classified as maximal response.
The study is initiated as a feasibility study (part one)and will continue into the expansion trial after interim analysis.(part two)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Standard of care
Response evaluation using imaging-based RECIST according to standard guidelines.
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 therapy approach
Response evaluation will be performed using ctDNA-RECIST instead of imaging.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
* Pregnant (positive pregnancy test) or breast-feeding women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vejle Hospital
OTHER
Karen-Lise Garm Spindler
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karen-Lise Garm Spindler
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen-Lise G Spindler, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital
Aarhus, , Denmark
Department pf Oncology, Vejle Hospital
Vejle, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Karen-Lise G Spindler
Role: primary
Torben F Hansen
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KFE 2406
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.