Solid TumorSOFTNCT04407897
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
A study testing Stereotactic radiotherapy in people with Solid Tumor and Oligometastases, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumor, Oligometastases, Soft Tissue Disease
- What is being tested?
- Stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Oct 2019to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor, Oligometastases, Soft Tissue Disease
- Being tested
- Stereotactic radiotherapy
- Keywords
- SBRT, SABR, MR-guided radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR. Receives: Radiation: Stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 1 year.
Secondary outcomes (3)
Freedom from local progression.
Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.
Measured: 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 .
Measured: 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.
Measured: Assessed at week 6, 12, 24, 36, and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start7 Oct 2019
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Henry Ford Hospital
- Responsible party
- Principal investigator, Mette Felter, Herlev Hospital
- Investigators
- Mette Felter, MD, Principal investigator, Helev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407897
- Sponsor's protocol ID
- H-19014486
- Acronym
- SOFT
- Status last verified
- Apr 2022
- First submitted
- 17 May 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39880308van 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.
PubMed 38224916
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases
- ClinicalTrials.gov ID
- NCT04407897
- Acronym / sponsor ID
- SOFT / H-19014486
- Conditions
- Solid Tumor, Oligometastases, Soft Tissue Disease
- Keywords
- SBRT, SABR, MR-guided radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Henry Ford Hospital
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Stereotactic radiotherapyPatients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (8 listed)
- Patient cannot tolerate physical set up required for SABR.
- Active bowel obstruction.
- Uncontrolled intercurrent illness.
- Medical contraindication to undergoing MR-imaging.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiotherapyThree different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions. | Radiation | Radiotherapy |
Primary outcome
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.
3 secondary outcomes
Freedom from local progression.
Time frame: Assessed at week 6, 12, 24, 36, and 52.
Progression free survival.
Time frame: Assessed at week 6, 12, 24, 36, and 52.
Time to progression (TTP) outside the radiation field.
Time frame: Assessed at week 6, 12, 24, 36, and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 39880308van 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.
- Derived from this study: PubMed 38224916van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Felter, MD principal investigator
Helev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy in people with Solid Tumor and Oligometastases, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE). (time frame: Assessed at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.