Gastrointestinal NeoplasmPhase 2ctDNA-RECISTNCT06562348
The ctDNA-RECIST Trial Part One
A Phase 2 study testing ctDNA-RECIST guided palliative systemic treatment in people with Gastrointestinal Neoplasm, run by Karen-Lise Garm Spindler at 2 sites in Denmark.
Trial summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm
- What is being tested?
- ctDNA-RECIST guided palliative systemic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Jan 2025to 1 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Torben F Hansen, MD, Prof contact
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Karen-Lise G Spindler
- Recruiting
Department pf Oncology, Vejle Hospital
Vejle, 7100
Torben F Hansen
About this study
Official title: ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Read the 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.
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
- Gastrointestinal Neoplasm
- Being tested
- Standard of care, ctDNA-RECIST guided palliative systemic treatment
- Keywords
- Circulating Tumor DNA, Liquid Biopsy, Gastrointestinal Neoplasm, Metastatic
- Medical subject headings
- Gastrointestinal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
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 treatmentOther
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 group | Role | What they receive |
|---|---|---|
| A: Standard of care | Active comparator | Response evaluation using imaging-based RECIST according to standard guidelines. Receives: Other: Standard of care |
| ctDNA-RECIST guided therapy approach | Experimental | Response evaluation will be performed using ctDNA-RECIST instead of imaging. Receives: Other: ctDNA-RECIST guided palliative systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with protocol
The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion.
Measured: 3 months
Secondary outcomes (3)
Number of treatment cycles
Median number of treatment cycles in the two arms during the first 12 month of stuydy participation
Measured: 1 year
Response rate Arm A
Overall best response and response rate per RECIST during first-line treatment
Measured: 1 year
ctDNA response rate Arm B
Overall best response and response rate per ctDNA-RECIST during first-line treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Jan 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open label 1:1 randomized phase II trial
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen-Lise Garm Spindler
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital
- Responsible party
- Sponsor-investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
- Investigators
- Karen-Lise G Spindler, MD, Prof, Principal investigator, Department of Oncology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562348
- Sponsor's protocol ID
- KFE 2406
- Acronym
- ctDNA-RECIST
- Status last verified
- Apr 2025
- First submitted
- 14 Aug 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
- ClinicalTrials.gov ID
- NCT06562348
- Acronym / sponsor ID
- ctDNA-RECIST / KFE 2406
- Conditions
- Gastrointestinal Neoplasm
- Keywords
- Circulating Tumor DNA, Liquid Biopsy, Gastrointestinal Neoplasm, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Karen-Lise Garm SpindlerUniversity, hospital or other
- Collaborators
- Vejle Hospital
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label 1:1 randomized phase II trial
| Arm | Type | Receives |
|---|---|---|
| A: Standard of care | Active comparator | Other: Standard of careResponse evaluation using imaging-based RECIST according to standard guidelines. |
| ctDNA-RECIST guided therapy approach | Experimental | Other: ctDNA-RECIST guided palliative systemic treatmentResponse evaluation will be performed using ctDNA-RECIST instead of imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of carePatients 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. | Other | A: Standard of care |
| ctDNA-RECIST guided palliative systemic treatmentPatients 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. | Other | ctDNA-RECIST guided therapy approach |
Primary outcome
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.
3 secondary outcomes
Number of treatment cycles
Time frame: 1 year
Response rate Arm A
Time frame: 1 year
ctDNA response rate Arm B
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torben F Hansen, MD, Prof contact
Karen-Lise G Spindler, MD, Prof principal investigator
Department of Oncology, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ctDNA-RECIST guided palliative systemic treatment in people with Gastrointestinal Neoplasm, run by Karen-Lise Garm Spindler at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen-Lise G Spindler, MD, Prof (+4591167244, k.g.spindler@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with protocol (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.