RecruitingNot ApplicableNCT06462963

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


Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

302 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This trial compares delivering cancer-targeting radiation (SBRT — stereotactic body radiotherapy) in a single large dose versus multiple smaller doses for people with oligometastatic cancer (cancer with a limited number of spread sites). The goal is to find the safest and most effective approach. **You may be eligible if...** - You are already part of the OligoCare cohort study - All of your active cancer sites (primary tumor and metastases) were or will be treated with a goal of eliminating the cancer (radical intent) - All lesions planned for radiation are technically suitable for single-fraction SBRT - You have provided written informed consent **You may NOT be eligible if...** - Any of your target lesions are near sensitive structures such as the main airways, esophagus, spinal cord, or major digestive organs - Any metastasis is larger than 5 cm - Your doctor judges that single-fraction SBRT poses too high a risk for your specific lesion location Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONsingle-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.

RADIATIONmultiple-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.


Locations(15)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

AZ Groeninge Kortrijk

Kortrijk, Belgium

Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus

Wilrijk, Belgium

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Istituto Clinico Humanitas

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Sacro Cuore Hospital

Negrar, Italy

Policlinico Universitario Campus Bio-Medico- Oncology Center

Roma, Italy

Universita Di Torino

Torino, Italy

Radiotherapiegroep Arnhem

Deventer, Netherlands

Radboudumc - Radboud University Medical Center Nijmegen

Nijmegen, Netherlands

Inselspital - Inselspital

Bern, Switzerland

UniversitaetsSpital Zurich

Zurich, Switzerland

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NCT06462963


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