Clinical trial NCT04407897: SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Official title: SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Oligometastases
Soft Tissue Disease
Keywords: SBRT
SABR
MR-guided radiotherapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Rigshospitalet, Denmark
name: Henry Ford Hospital
First posted: 2020-05-29
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
timeFrame: Assessed at 1 year.
Secondary outcomes:
measure: Freedom from local progression.
timeFrame: Assessed at week 6, 12, 24, 36, and 52.
measure: Progression free survival.
timeFrame: Assessed at week 6, 12, 24, 36, and 52.
measure: Time to progression (TTP) outside the radiation field.
timeFrame: Assessed at week 6, 12, 24, 36, and 52.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Helev Hospital
name: Mette Felter, MD
role: PRINCIPAL_INVESTIGATOR
References: