Clinical trial · Interventional
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
NCT04407897CI-TRIAL-00058101SOFTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastases | — | UNRESOLVED | — |
| Soft Tissue Disease | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.
- interventionNames
- Radiation: Stereotactic radiotherapy
Primary outcomes (1)
- measure
- Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
- timeFrame
- Assessed at 1 year.
- description
- Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Secondary outcomes (3)
- measure
- Freedom from local progression.
- timeFrame
- Assessed at week 6, 12, 24, 36, and 52.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histology or cytology proven non-haematological cancer. * At least one metastasis should be localized in the infra-diaphragmatic soft tissue. * Eastern Cooperative Oncology Group (ECOG) scale of performance status ≤ 2. * ≥ 18 years old. * Life expectancy \> 6 months. * Target diameter (GTV) ≤ 5 cm. * Metastatic lesions must be visible, imaging defined targets and suitable for treatment with SABR. * In case of de novo OMD and oligometastatic recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed. * In case of oligoprogressive disease (OPD) \* and induced OMD \*\* only 3 metastases (including the primary tumour) are allowed. * All metastatic sites are treated or planned for ablative therapy (including surgery). For OPD, only the sites in progression is required to fulfil this criterion. * A baseline scan within 28 days of inclusion (PET-CT or CT and MR scanning). * No curative intended treatment option available. * An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide. * Ability to understand and the willingness to sign a written informed consent document. * If the target is in the liver, a Child-Pugh Score A is required. Exclusion Criteria: * Patient cannot tolerate physical set up required for SABR. * Active bowel obstruction. * Uncontrolled intercurrent illness. * Medical contraindication to undergoing MR-imaging. * Pregnancy. * Patients with uncontrolled brain metastases. * Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis. * If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints.
References
Publications (2)
- DERIVEDvan 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. PMID 39880308
- DERIVEDvan 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. PMID 38224916