Oligometastases, Soft Tissue Disease, Solid Tumor
Conditions
Keywords
SBRT, SABR, MR-guided radiotherapy
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 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.
Interventions
RADIATIONStereotactic 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.
Sponsors
Odense University Hospital
Rigshospitalet, Denmark
Henry Ford Hospital
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE). | Assessed at 1 year. | Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from local progression. | Assessed at week 6, 12, 24, 36, and 52. | Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria. |
| Progression free survival. | Assessed at week 6, 12, 24, 36, and 52. | The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 . |
| Time to progression (TTP) outside the radiation field. | Assessed at week 6, 12, 24, 36, and 52. | 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. |
Countries
Denmark
Outcome results
None listed