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

NCT06462963 | Recruiting DMC

• 1 other identifier: EORTC-2387
• Study Type: interventional
• Target: 302
• Locations: 4 countries
• Sites: 15

Brief 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.

Conditions

Breast Cancer; Prostate Cancer; NSCLC; Colorectal Cancer; Oligometastatic Disease

Keywords

radiotherapy; SBRT; TwiCs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression free survival (PFS)

  4.5 years from first patient in

• Overall survival (OS)

  4.5 years from first patient in

• Local control (LC)

  4.5 years from first patient in

• Pattern of progression of primary disease and metastases

  4.5 years from first patient in

Other Outcomes (3)

• Health-related Quality of life (HRQoL)

  4.5 years from first patient in

• Health-related Quality of life (HRQoL)

  4.5 years from first patient in

• Economic impact of radiation treatment

  4.5 years from first patient in

Study Arms (2)

single-fraction SBRT

EXPERIMENTAL

All lesions to be treated with radical radiotherapy will be treated with single-fraction SBRT, delivered using a dose ranging from 16 Gy to 34 Gy, depending on metastasis location. Acceptable ablative doses are developed in the protocol (see Section 6.4). Radiotherapy treatment will last from one single visit to a few weeks, depending on the number of treated metastases.

Radiation: single-fraction SBRT

multiple-fraction SBRT

ACTIVE COMPARATOR

All lesions to be treated with radical radiotherapy will be treated with multiple-fraction SBRT.

Radiation: multiple-fraction SBRT

Interventions

single-fraction SBRT RADIATION

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.

single-fraction SBRT

multiple-fraction SBRT RADIATION

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.

multiple-fraction SBRT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (15)

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, 3010, Switzerland

RECRUITING

UniversitaetsSpital Zurich

Zurich, 8901, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Matthias Guckenberger, MD

  Radiation Oncology, University of Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

• Piet Ost, MD

  GZA Sint-Augustinus, Wilrijk, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EORTC HQ

CONTACT

+32 2 774 16 11; eortc@eortc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 17, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): February 15, 2029
• Study Completion (Estimated): February 15, 2029
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

BE (5); NL (2); IT (6); CH (2)