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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor; Oligometastases; Soft Tissue Disease
• Intervention / Treatment: Radiation: Stereotactic radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Radiotherapy; Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Odense University Hospital; Rigshospitalet, Denmark; Henry Ford Hospital
• Investigators: Principal Investigator: Mette Felter, MD, Helev Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2019
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (ACTUAL): May 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SBRT; SABR; MR-guided radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: H-19014486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No