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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

Tracking Information
First Submitted Date  ICMJE May 17, 2020
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date September 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • 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.
  • 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 .
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
Official Title  ICMJE SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Solid Tumor
  • Oligometastases
  • Soft Tissue Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Radiotherapy
Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.
Intervention: Radiation: Stereotactic radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
61
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 7, 2022
Estimated Primary Completion Date September 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04407897
Other Study ID Numbers  ICMJE H-19014486
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mette Felter, Herlev Hospital
Study Sponsor  ICMJE Herlev Hospital
Collaborators  ICMJE
  • Odense University Hospital, Denmark
  • Rigshospitalet, Denmark
  • Henry Ford Hospital
Investigators  ICMJE
Principal Investigator: Mette Felter, MD Helev Hospital
PRS Account Herlev Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP