SABR-COMET 10 - V1.0 05Nov2018
Research type
Research Study
Full title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
IRAS ID
269164
Contact name
Stephen Harrow
Contact email
Sponsor organisation
London Health Sciences Centre (LHSC
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
GN19ON604,
Duration of Study in the UK
8 years, 6 months, 24 days
Research summary
When cancer has spread from an original tumour to other sites of the body, it is classified as metastatic and when there are only a few locations of metastatic cancer this is referred to as oligo-metastatic). Generally, for patients with metastatic cancer, the goal of treatment has been to slow down the cancer growth with chemotherapy and/or radiation, but treatments have been unable to get rid of the cancer altogether. However, some studies suggest that by removing or killing each of those cancer deposits, the cancer may be controlled for a longer period of time.
Historically, evidence to support the oligometastatic state has consisted of single-arm, non-randomised studies without controls and it has been suggested the long-term survivals achieved in patients with oligometastases after ablative therapies is merely due to the selection of very fit patients with slow growing tumours, since randomised evidence to support the oligometastatic paradigm has been lacking. However, some recent randomised phase II trials now provide some supporting evidence of an oligometastatic state.
SABR (Stereotactic ablative body radiation) is a radiation treatment that delivers high-dose, precise radiation to small tumours over 1-2 weeks. This new technique can potentially allow radiation to be focused more precisely, and delivered more accurately than with conventional radiotherapy treatments. SABR could improve the chance of controlling the cancer and help reduce side effects by more precisely treating the cancer.
This study aims to assess the impact of SABR in addition to standard of care, compared to standard of care treatment alone, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumour and 4-10 metastatic lesions. This study is currently open in Canada and this application is to enable this study to be conducted at the Beatson Glasgow Cancer Centre, Scotland.
REC name
West of Scotland REC 1
REC reference
20/WS/0092
Date of REC Opinion
10 Aug 2020
REC opinion
Further Information Favourable Opinion