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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.
Herlev Hospital
Herlev, Denmark
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.
Time frame: Assessed at 1 year.
Freedom from local progression.
Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.
Time frame: Assessed at week 6, 12, 24, 36, and 52.
Progression free survival.
The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .
Time frame: 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.
Time frame: Assessed at week 6, 12, 24, 36, and 52.
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