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

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ClinicalTrials.gov Identifier: NCT04407897
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Odense University Hospital, Denmark
Rigshospitalet, Denmark
Henry Ford Hospital
Information provided by (Responsible Party):
Mette Felter, Herlev Hospital

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

Condition or disease Intervention/treatment Phase
Solid Tumor Oligometastases Soft Tissue Disease Radiation: Stereotactic radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : September 7, 2021
Estimated Study Completion Date : September 7, 2022

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.




Primary Outcome Measures :
  1. Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE). [ Time Frame: Assessed at 1 year. ]
    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 :
  1. Freedom from local progression. [ Time Frame: Assessed at week 6, 12, 24, 36, and 52. ]
    Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.

  2. Progression free survival. [ Time Frame: Assessed at week 6, 12, 24, 36, and 52. ]
    The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .

  3. Time to progression (TTP) outside the radiation field. [ Time Frame: Assessed at week 6, 12, 24, 36, and 52. ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407897


Contacts
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Contact: Mette Felter, MD +45 38686166 mette.van.overeem.felter@regionh.dk
Contact: Gitte F. Persson, Ass. prof. +45 38689299 gitte.persson.03@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Mette Felter, MD    +45 38686166    mette.van.overeem.felter@regionh.dk   
Contact: Gitte Persson, Ass. Prof.    +45 38689299    gitte.persson.03@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Odense University Hospital, Denmark
Rigshospitalet, Denmark
Henry Ford Hospital
Investigators
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Principal Investigator: Mette Felter, MD Helev Hospital
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Responsible Party: Mette Felter, Principal Investigator, MD, Mette Felter, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04407897    
Other Study ID Numbers: H-19014486
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mette Felter, Herlev Hospital:
SBRT
SABR
MR-guided radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes