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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Henry Ford Hospital | OTHER |
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The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.
The investigators wish to evaluate the safety and feasibility of MR-guided stereotactic radiation to patients with infra-diaphragmatic oligometastatic disease including quality of life assessments and patient-reported outcome measures. Further, the investigators assess clinical response among patients with oligometastatic disease (OMD), defined as up to five metastases in up to three different organs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiotherapy | Radiation | Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE). | Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0. | Assessed at 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from local progression. | Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria. | Assessed at week 6, 12, 24, 36, and 52. |
| Progression free survival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette Felter, MD | Helev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39880308 | Derived | van Overeem Felter M, Moller PK, Josipovic M, Bekke SN, Bernchou U, Serup-Hansen E, Parikh P, Kim J, Geertsen P, Behrens CP, Madsen K, Vogelius IR, Topsoe JF, Berthelsen AK, Pohl M, Schytte T, Persson GF. 1-year efficacy results after MR-guided risk-adapted stereotactic radiotherapy of infra-diaphragmatic oligometastases in a multicenter phase II trial. Radiother Oncol. 2025 Apr;205:110748. doi: 10.1016/j.radonc.2025.110748. Epub 2025 Jan 27. | |
| 38224916 |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
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The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .
| Assessed at week 6, 12, 24, 36, and 52. |
| Time to progression (TTP) outside the radiation field. | Defined as the time from inclusion until progression outside the radiation field determined by a CT, MR, or PET-CT per RECIST 1.1. Outside the radiation field is defined as outside and not adjacent to the PTV. | Assessed at week 6, 12, 24, 36, and 52. |
| Derived |
| van Overeem Felter M, Moller PK, Josipovic M, Bekke SN, Bernchou U, Serup-Hansen E, Madsen K, Parikh PJ, Kim J, Geertsen P, Behrens CP, Vogelius IR, Pohl M, Schytte T, Persson GF. MR-guided stereotactic radiotherapy of infra-diaphragmatic oligometastases: Evaluation of toxicity and dosimetric parameters. Radiother Oncol. 2024 Mar;192:110090. doi: 10.1016/j.radonc.2024.110090. Epub 2024 Jan 13. |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |