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

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jun 11, 2024

Keywords

ClinConnect Summary

The OligoCare TwiCs trial, also known as the SPRINT trial, is studying the effectiveness and safety of a treatment called single-fraction stereotactic body radiation therapy (SBRT) for patients with certain types of cancer that have spread to a limited number of locations in the body, known as oligometastatic disease. This trial aims to compare this single-fraction approach—where patients receive one large dose of radiation—to the standard treatment, which involves receiving several smaller doses over time. The main goal is to find out if the single-fraction treatment is just as safe and effective as the traditional method.

To participate in this trial, patients must be part of the OligoCare cohort and have active cancer lesions that are suitable for this type of treatment. They will need to give their consent to be part of the study and may be randomly assigned to either the single-fraction treatment or the standard treatment group. It’s important to note that some patients may not be eligible for the trial if their cancer lesions are near sensitive areas in the body or if they are too large. Overall, this trial offers a chance for patients to receive innovative treatment while contributing to important research that could improve cancer care in the future.

Gender

ALL

Eligibility criteria

• 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.