Trials / Unknown
UnknownNCT04407897
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Herlev Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic radiotherapy | Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions. |
Timeline
- Start date
- 2019-10-07
- Primary completion
- 2023-04-01
- Completion
- 2023-04-01
- First posted
- 2020-05-29
- Last updated
- 2022-04-28
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04407897. Inclusion in this directory is not an endorsement.