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

July 30, 2025 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As a consequence of improved survival of metastatic cancer patients due to more effective systemic therapy, focused radiotherapy in the form of stereotactic body radiotherapy (SBRT) has become a standard of care in many clinical situations to achieve durable symptom and / or metastasis control: treatment of brain metastases, of painful bone or spinal metastases and especially as local treatment in a multimodality treatment strategy for oligometastatic disease. These indications are supported by international practice guidelines, e.g. ESMO guidelines for NSCLC and colorectal cancer; and NCCN guidelines for NSCLC, prostate cancer, renal cell cancer, colorectal cancer and sarcoma.

However, despite the universal use of SBRT in the local treatment of oligometastases, the level of evidence supporting stereotactic radiotherapy is low, apart from few small prospective clinical trials showing a very favourable toxicity profile of SBRT and promising efficacy data. In this context, the OligoCare research project, a prospective observational cohort study, has been developed within the E²-RADIatE platform. The aim of this project is to collect real-world data on SBRT treatment of patients with oligometastatic disease of primary breast, prostate, lung and colorectal cancer, with no limit on the maximum number of treated metastases.

Yet, the local treatment of multiple metastases poses several challenges. One of them is the integration of local metastases-directed SBRT into a systemic treatment strategy: in an interim analysis of the OligoCare cohort, almost all patients were treated with fractionated SBRT and the median number of SBRT fractions was 5. This would result in a total of 50 SBRT fractions in a patient with 10 metastases. Considering that several drugs are paused before and after SBRT, the systemic therapy free interval could last for almost 2 months, which one could consider as unacceptably long in metastatic cancer patients.

One solution to this problem would be the delivery of radiotherapy in a smaller number of SBRT fractions, preferably as single-fraction SBRT. Single-fraction SBRT has been described since the 90's for treatment of liver metastases, lung metastases or vertebral metastases. A recent randomized phase II trial compared multiple-fraction vs single-fraction SBRT for pulmonary oligometastases (n=90) and did not observe differences in toxicity or any oncological outcome parameter.

Nevertheless, single-fraction SBRT still lacks adoption in the radiation oncology community. Likely reasons are the experience of single-fraction SBRT restricted to small, highly specialized centers, the small number of patients treated with single-fraction SBRT in the literature and the concerns of potentially increased toxicity and / or decreased efficacy.

There is consequently a strong rationale to implement and evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current SoC of multiple-fraction SBRT.

This question will be addressed in the current Trials within Cohorts (TwiCs) study, in which patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT. The main hypothesis is that single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.

Study Type

Interventional

Enrollment (Estimated)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Aalst, Belgium
        • Not yet recruiting
        • Onze Lieve Vrouw Ziekenhuis
      • Brussel, Belgium
        • Not yet recruiting
        • Institut Jules Bordet
      • Gent, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgium
        • Not yet recruiting
        • AZ Groeninge Kortrijk
      • Wilrijk, Belgium
        • Not yet recruiting
        • Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus
  • Italy
      • Firenze, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi
      • Milano, Italy
        • Not yet recruiting
        • Istituto Europeo di Oncologia
      • Milano, Italy
        • Not yet recruiting
        • Istituto Clinico Humanitas
      • Negrar, Italy
        • Not yet recruiting
        • Sacro Cuore Hospital
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Universitario Campus Bio-Medico- Oncology Center
      • Torino, Italy
        • Not yet recruiting
        • Università di Torino
  • Netherlands
      • Deventer, Netherlands
        • Not yet recruiting
        • Radiotherapiegroep Arnhem
      • Nijmegen, Netherlands
        • Not yet recruiting
        • Radboudumc - Radboud University Medical Center Nijmegen
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital - Inselspital
      • Zürich, Switzerland, 8901
        • Recruiting
        • UniversitaetsSpital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-fraction SBRT

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
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.
Active Comparator: multiple-fraction SBRT
All lesions to be treated with radical radiotherapy will be treated with multiple-fraction SBRT.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3+ SBRT-related toxicity
Time Frame: 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.
within 12 months following treatment with radical radiotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 4.5 years from first patient in
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)
Time Frame: 4.5 years from first patient in
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)
Time Frame: 4.5 years from first patient in
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
Time Frame: 4.5 years from first patient in
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

Outcome Measure
Measure Description
Time Frame
Health-related Quality of life (HRQoL)
Time Frame: 4.5 years from first patient in
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)
Time Frame: 4.5 years from first patient in
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
Time Frame: 4.5 years from first patient in
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Matthias Guckenberger, MD, Radiation Oncology, University of Zurich, Switzerland
  • Principal Investigator: Piet Ost, MD, GZA Sint-Augustinus, Wilrijk, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

February 15, 2029

Study Completion (Estimated)

February 15, 2029

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-2387

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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