SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases

Herlev Hospital

Status

Unknown

Conditions

Oligometastases

Solid Tumor

Soft Tissue Disease

Treatments

Radiation: Stereotactic radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04407897

H-19014486

Details and patient eligibility

About

The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.