Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vejle Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
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:
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Standard of care | Active Comparator | Response evaluation using imaging-based RECIST according to standard guidelines. |
|
| ctDNA-RECIST guided therapy approach | Experimental | Response evaluation will be performed using ctDNA-RECIST instead of imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with protocol | The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment cycles | Median number of treatment cycles in the two arms during the first 12 month of stuydy participation | 1 year |
| Response rate Arm A | Overall best response and response rate per RECIST during first-line treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen-Lise G Spindler, MD, Prof | Contact | +4591167244 | k.g.spindler@rm.dk | |
| Torben F Hansen, MD, Prof | Contact | torben.hansen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler, MD, Prof | Department of Oncology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8000 | Denmark |
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
An open label 1:1 randomized phase II trial
Not provided
Not provided
Not provided
Not provided
|
| ctDNA-RECIST guided palliative systemic treatment | Other | 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. |
|
| 1 year |
| ctDNA response rate Arm B | Overall best response and response rate per ctDNA-RECIST during first-line treatment | 1 year |
| Department pf Oncology, Vejle Hospital | Recruiting | Vejle | 7100 | Denmark |
|
| D005767 |
| Gastrointestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |