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

Solid Tumor Clinical Trial

— SOFT  

Official title:

SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04407897
• Other study ID #: H-19014486
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2022
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Oligometastases
• Soft Tissue Disease
• Solid Tumor

Intervention

Radiation:
• Stereotactic 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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Herlev Hospital	Henry Ford Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative CTCAE grade = 4 SABR related toxicity (TRAE).	Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.	Assessed at 1 year.
Secondary	Freedom from local progression.	Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.	Assessed at week 6, 12, 24, 36, and 52.
Secondary	Progression free survival.	The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .	Assessed at week 6, 12, 24, 36, and 52.
Secondary	Time to progression (TTP) outside the radiation field.	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.	Assessed at week 6, 12, 24, 36, and 52.