OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
NCT Number: NCT06462963
Acronym: SPRINT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Prostate Cancer|NSCLC|Colorectal Cancer|Oligometastatic Disease
Interventions: RADIATION: single-fraction SBRT|RADIATION: multiple-fraction SBRT
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 302
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-15
Completion Date: 2028-11-15

Summary:
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT.

The main question/hypothesis this clinical trial aims to answer is:

- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.

Patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.

Primary Outcome Measures: Grade 3+ SBRT-related toxicity, The cumulative incidence of grade 3+ SBRT-related toxicity within 12 months following treatment with radical radiotherapy. This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting., within 12 months following treatment with radical radiotherapy.
Secondary Outcome Measures: Progression free survival (PFS), defined as the time from the date of randomization to the date of first progression (local, regional or distant) as per local assessment or death., 4.5 years from first patient in|Overall survival (OS), defined as the time from the date of randomization to the date of death from any cause., 4.5 years from first patient in|Local control (LC), defined as freedom from local metastasis (inside the PTV or prior treated field)., 4.5 years from first patient in|Pattern of progression of primary disease and metastases, Pattern of progression of primary disease and metastases includes local, regional and/or distant progression or recurrence., 4.5 years from first patient in
Other Outcome Measures: Health-related Quality of life (HRQoL), The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30., 4.5 years from first patient in|Health-related Quality of life (HRQoL), The magnitude of change in HRQoL in terms of pain/discomfort from EQ5D-5L questionnaires., 4.5 years from first patient in|Economic impact of radiation treatment, To document the health economic impact of the two treatments by collecting Use of resources questionnaires during radiation treatment and during follow up., 4.5 years from first patient in