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Clinical Trials in Belgium / NCT06462963
Recruiting Not applicable

OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)

NCT06462963 · tracked via the Priya Life Science Belgium tracker
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Phase
Not applicable
Started
2025-04-15
Last updated
2025-08-01

Condition(s) studied

Breast CancerProstate CancerNSCLCColorectal CancerOligometastatic Disease

Investigational drug(s) / intervention(s)

single-fraction SBRTmultiple-fraction SBRT

single-fraction SBRT: Single-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers a high dose of radiation in a single treatment session to a targeted area, often used for treating small, well-defined tumors. This approach minimizes exposure to surrounding healthy tissues while effectively treating the tumor.

multiple-fraction SBRT: Multiple-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers high doses of radiation over several treatment sessions to a targeted area, typically used for treating small, well-defined tumors. This method helps to further protect surrounding healthy tissues by spreading the total radiation dose over multiple sessions.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be treated with radical intent (surgery or radiotherapy). * All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed. * Written informed consent must be given according to ICH/GCP, and national/local regulations. Patients will be consented in a step-wise approach. Step 1 \[both control and experimental arms\]: patients will need to consent to be included and evaluated in E²-RADIatE (that includes the non-interventional OligoCare prospective registry cohort) and to potentially be randomized to future sub-studies for which they are eligible; no further consent will be sought if they are randomized to the SoC (control) arm; Step 2 \[experimental arm only\]: if eligible for the current sub-study and randomized to receive single-fraction SBRT, patients will need to consent to receiving the experimental treatment. Exclusion Criteria: All targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following lesions are systematically excluded: * Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus * Metastases within \< 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel * Metastases within \< 5 mm of the spinal cord, the cauda equina or the brachial plexus * Metastases \> 5 cm in largest diameter.

Primary outcome measure(s)

  • Grade 3+ SBRT-related toxicity — within 12 months following treatment with radical radiotherapy.
    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.

Trial sites (15)

FacilityCityRegionStatus
Onze Lieve Vrouw Ziekenhuis Aalst Belgium Not Yet Recruiting
Institut Jules Bordet Brussels Belgium Not Yet Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Not Yet Recruiting
AZ Groeninge Kortrijk Kortrijk Belgium Not Yet Recruiting
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus Wilrijk Belgium Not Yet Recruiting
Azienda Ospedaliero-Universitaria Careggi Florence Italy Not Yet Recruiting
Istituto Clinico Humanitas Milan Italy Not Yet Recruiting
Istituto Europeo di Oncologia Milan Italy Not Yet Recruiting
Sacro Cuore Hospital Negrar Italy Not Yet Recruiting
Policlinico Universitario Campus Bio-Medico- Oncology Center Roma Italy Not Yet Recruiting
Universita Di Torino Torino Italy Not Yet Recruiting
Radiotherapiegroep Arnhem Deventer Netherlands Not Yet Recruiting
Radboudumc - Radboud University Medical Center Nijmegen Nijmegen Netherlands Not Yet Recruiting
Inselspital - Inselspital Bern Switzerland Recruiting
UniversitaetsSpital Zurich Zurich Switzerland Recruiting

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Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06462963 on ClinicalTrials.gov ↗ ← All trials in Belgium