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
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Oligometastases Soft Tissue Disease||Radiation: Stereotactic radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|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)|
|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|
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.
- 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.
- 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.
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
|Contact: Mette Felter, MD||+45 firstname.lastname@example.org|
|Contact: Gitte F. Persson, Ass. prof.||+45 email@example.com|
|Principal Investigator:||Mette Felter, MD||Helev Hospital|