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

Primary Purpose

Solid Tumor, Oligometastases, Soft Tissue Disease

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring SBRT, SABR, MR-guided radiotherapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Freedom from local progression.
Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.
Progression free survival.
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.
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.

Full Information

First Posted
May 17, 2020
Last Updated
April 27, 2022
Sponsor
Herlev Hospital
Collaborators
Odense University Hospital, Rigshospitalet, Denmark, Henry Ford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04407897
Brief Title
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Acronym
SOFT
Official Title
SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Odense University Hospital, Rigshospitalet, Denmark, Henry Ford Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Oligometastases, Soft Tissue Disease
Keywords
SBRT, SABR, MR-guided radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.
Primary Outcome Measure Information:
Title
Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
Description
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Time Frame
Assessed at 1 year.
Secondary Outcome Measure Information:
Title
Freedom from local progression.
Description
Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.
Time Frame
Assessed at week 6, 12, 24, 36, and 52.
Title
Progression free survival.
Description
The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .
Time Frame
Assessed at week 6, 12, 24, 36, and 52.
Title
Time to progression (TTP) outside the radiation field.
Description
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.
Time Frame
Assessed at week 6, 12, 24, 36, and 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Felter, MD
Organizational Affiliation
Helev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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