Status:
UNKNOWN
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Odense University Hospital
Rigshospitalet, Denmark
Conditions:
Solid Tumor
Oligometastases
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04407897
Start Date
October 7 2019
End Date
April 1 2023
Last Update
April 28 2022
Active Locations (1)
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1
Herlev Hospital
Herlev, Denmark