SIMPLIFY-SABR-COMET
Research type
Research Study
Full title
Single vs. Multiple fraction non-Inferiority trial of Stereotactic Ablative Radiotherapy for the Comprehensive treatment of Oligo-metastases/progression: SIMPLIFY-SABR-COMET
IRAS ID
340316
Contact name
Iain Phillips
Contact email
Sponsor organisation
BC Cancer- Prince George
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 5 months, days
Research summary
Traditionally, patients with cancers that have spread to a few areas or have started to grow in new spots have been treated mainly with systemic therapies like chemotherapy, hormonal treatments, targeted therapies, and immune therapies. These treatments aim to slow down the disease and extend life, but they are not meant to cure. On the other hand, treatments like radiation therapy (RT) and surgery have typically been used to ease symptoms. SABR (Stereotactic Ablative Radiotherapy) is a newer type of radiation therapy that targets tumors with high doses of radiation, but it requires more planning, takes more time, costs more, and could cause more side effects. Regular RT can be given in different ways: as a single dose or in several doses spread out over time, depending on where the cancer is. SABR, however, usually involves no more than eight doses. Multiple-dose RT is used to spread out the radiation, which may reduce long-term side effects, while single-dose RT is cheaper and saves patients time. While a single dose of SABR has been shown to be safe and effective for brain cancer, we still don’t fully understand its side effects for other types of metastatic cancer.
This clinical trial will compare the safety, effectiveness, and costs of single-dose (SF) and multiple-dose (MF) SABR for patients with 1-5 metastatic or progressive cancer spots. We plan to recruit 598 patients from at least 20 centers worldwide. We expect it will take five years to enroll all patients, with follow-up visits for another five years. The overall duration of the study will be 10.5 years. Patients will be randomly assigned to receive either SF or MF SABR. The main goal of the study is to see if SF SABR causes fewer serious side effects than MF SABR. We’ll also compare how well the treatments control the cancer, how long patients live without their cancer progressing, and the patients' quality of life and reported side effects.
REC name
South East Scotland REC 01
REC reference
25/SS/0016
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion