Radiotherapy in patients with rare oligometastatic cancers

Radiotherapy in patients with rare oligometastatic cancers

Stereotactic body radiotherapy in addition to standard of care treatment in patients with rare oligometastatic cancer (OligoRARE): a randomised, phase III, open-label trial 

Status
In preparation
 
Cancer types
  • Solid tumours
Trial phase
3

Funding

€400,000
ACF donation
€1,894,868
Estimated trial cost

Why this trial?

Metastatic cancer can range from a single metastasis to widely disseminated metastases, making it the leading cause of cancer death. Oligometastasis is considered to be an intermediate state between locoregional cancer and widespread metastases with a limited number of lesions and organs involved. Because of its limited spread, it has been shown in studies that metastasis-directed therapy (surgery or radiotherapy) added to standard of care might achieve long-term survival or even cure in about one quarter of the patients. 

Most trials in the field of oligometastatic disease concentrate in lung cancer, prostate cancer, breast cancer and colorectal cancer patients. But there is a strong scientific rational that metastasis-directed therapy, like radiotherapy, might be beneficial in the oligometastatic treatment of more rare cancer types. The aim of this study is to evaluate if the use of stereotactic body radiotherapy (SBRT) in oligometastatic patients with a cancer type other then lung, prostate, breast or colorectal cancer, would improve overall survival of these patients. 

The study focus has the potential to address the issue of differing radiobiology and SBRT efficacy across cancer types. These results could eventually help guide clinical decision making to the benefit of patients. 

Why this intervention?

Technological improvements in radiation therapy now enable the delivery of precisely targeted, high radiation doses. This stereotactic body radiotherapy (SBRT) has become a treatment standard for many different diseases, especially in oligometastatic disease where several metastases are to be treated in different anatomical locations (e.g. lung and liver). Additionally, SBRT is a non-invasive treatment delivered in few outpatient sessions and does therefore allow concomitant treatment with systemic therapy. 

One recent randomised trial (SABR COMET) allowed inclusion of oligometastatic cancer patients no matter the solid primary cancer and the addition of SBRT demonstrate an overall survival benefit in these patients.  

Trial design

The EORTC-1945 study is an international randomised multicentre open-label phase III trial of the effect of adding stereotactic body radiotherapy (SBRT) to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. In total, 200 patients with oligometastatic disease will be randomised between current standard of care treatment versus standard of care treatment plus SBRT.

Partners

Researchers:  

  • Dr. Matthias Guckenberger, University Hospital Zurich, Zurich, Switzerland (Study Coordinator)
  • Dr. Piet Ost, Universitair Ziekenhuis Gent, Gent, Belgium (Study Coordinator) 

Sponsor: 

  • European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium 

Other funding partner 

Our role

Financial support
Why we support this trial
Profit is a low priority in cancer treatment for the Anticancer Fund
Intervention has little or no commercial value
The Anticancer Fund wants to maximize the benefit for cancer patients
Expected survival benefit
The Anticancer Fund aims at no major hurdle for clinical implementation
No major hurdle for clinical implementation

Funding

€1,894,868
Estimated trial cost
€400,000
ACF donation
€3,133
ACF internal support
Questions about participation?
Questions about this trial?
The Anticancer Fund
studies [at] anticancerfund.org

References

More info: EORTC-1945

www.eortc.org/research_field/clinical-detail/1945/

David A. Palma, Robert Olson, Stephen Harrow, Stewart Gaede, Alexander V. Louie, Cornelis Haasbeek, et. Al. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. Journal of Clinical Oncology 2020 38:25, 2830-2838. DOI: 10.1200/JCO.20.00818 

Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol 1995;13:8–0. doi:10.1200/JCO.1995.13.1.8. 

Lewis SL, Porceddu S, Nakamura N, Palma DA, Lo SS, Hoskin P, et al. Definitive Stereotactic Body Radiotherapy (SBRT) for Extracranial Oligometastases. Am J Clin Oncol Cancer Clin Trials 2017;40:418–22. doi:10.1097/COC.0000000000000169. 

Palma DA, Olson R, Harrow S, Gaede S, Louie A V., Haasbeek C, et al. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet 2019;393:2051–8. doi:10.1016/S0140-6736(18)32487-5. 

Palma D, Olson R, Harrow S, Gaede S, Louie A V, Haasbeek C, et al. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. medRxiv 2020:2020.03.26.20044305. doi:10.1101/2020.03.26.20044305. 

Author: Kristine Beckers (Trial Manager) 

Last updated: February 2021