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

NCT04407897 | Unknown DMC

• 1 other identifier: H-19014486
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor; Oligometastases; Soft Tissue Disease

Keywords

SBRT; SABR; MR-guided radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Freedom from local progression.

  Assessed at week 6, 12, 24, 36, and 52.

• Progression free survival.

  Assessed at week 6, 12, 24, 36, and 52.

• Time to progression (TTP) outside the radiation field.

  Assessed at week 6, 12, 24, 36, and 52.

Study Arms (1)

Radiotherapy

EXPERIMENTAL

Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.

Radiation: Stereotactic radiotherapy

Interventions

Stereotactic radiotherapy RADIATION

Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.

Radiotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Henry Ford Hospital: collaborator

Study Sites (1)

Herlev Hospital

Herlev, Denmark

Location

Related Publications (2)

• van Overeem Felter M, Moller PK, Josipovic M, Bekke SN, Bernchou U, Serup-Hansen E, Parikh P, Kim J, Geertsen P, Behrens CP, Madsen K, Vogelius IR, Topsoe JF, Berthelsen AK, Pohl M, Schytte T, Persson GF. 1-year efficacy results after MR-guided risk-adapted stereotactic radiotherapy of infra-diaphragmatic oligometastases in a multicenter phase II trial. Radiother Oncol. 2025 Apr;205:110748. doi: 10.1016/j.radonc.2025.110748. Epub 2025 Jan 27.

  PMID: 39880308 DERIVED

• van Overeem Felter M, Moller PK, Josipovic M, Bekke SN, Bernchou U, Serup-Hansen E, Madsen K, Parikh PJ, Kim J, Geertsen P, Behrens CP, Vogelius IR, Pohl M, Schytte T, Persson GF. MR-guided stereotactic radiotherapy of infra-diaphragmatic oligometastases: Evaluation of toxicity and dosimetric parameters. Radiother Oncol. 2024 Mar;192:110090. doi: 10.1016/j.radonc.2024.110090. Epub 2024 Jan 13.

  PMID: 38224916 DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mette Felter, MD

  Helev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, Mette Felter

Model Details: This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 29, 2020
• Study Start: October 7, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)