In patients with a limited oligometastatic burden, emerging evidence suggests that treating all sites of disease with ablative therapies can improve patient outcomes, including overall survival and progression-free survival.
Aim of the study
This study is being conducted to investigate the effect of stereotactic radiotherapy on you during the treatment of your cancer and to compare this treatment with standard treatment. The study records the survival time, the occurrence of side effects and the quality of life.
Who can take part?
Patients with oligometastatic tumors
Procedure
The study has two treatment arms to which you will be randomly assigned. You have a 2/3 chance of being assigned to experimental treatment group 2.treatment group 1 (standard treatment):If you are assigned to this treatment group, you will receive palliative radiotherapy for all symptomatic metastases, i.e. for all metastases that are causing problems. Furthermore, metastases that could otherwise soon lead to complications can also be irradiated prophylactically. In addition to radiotherapy, you may receive chemotherapy, hormonal therapy or immunotherapy, depending on the standard of care, or it may be decided to forego systemic therapy and observe.Treatment group 2 (Experimental treatment):If you are assigned to this treatment group, all metastases will receive stereotactic radiotherapy. This high-dose radiotherapy is carried out in a similar way to any other modern radiotherapy, using precise three-dimensional positioning and image guidance for each radiation fraction. The total duration of an irradiation session is 10 to 30 minutes per irradiation volume, just like outside the study, and the pure irradiation time is significantly shorter; the dose in and directly at the tumor is 2 to 4 times higher than a standard palliative dose. For the surrounding healthy organs and the rest of the body, the calculated additional dose exposure is therefore "numerically" very different (depending on the size and localization of the target area), but in any case negligible thanks to the modern technical possibilities for "punctual" irradiation with a steep drop in dose. the purpose of this treatment is not only - as is usually the case - to reduce the symptoms by reducing the metastases, but also to achieve the longest possible disease control through the higher dose and the locally aggressive treatment of all visible tumor foci in the body. The initial results of studies in patients with 1 to 5 metastases seem to confirm this assumption. Following radiotherapy, you will receive standard treatment, such as chemotherapy, hormone therapy or immunotherapy, or it will be decided to forego systemic therapy and observe.
Compensation
None
Original study name
A randomized phase III trial of stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET 10)
BASEC number
2020-00300
Financial support from
London Health Sciences Center