The SPAR trial, which will test the effect of cholesterol medication on the treatment of patients with rectal cancer, has opened to recruitment. Laboratory tests have shown how statins sensitise cancer cells to radiation while protecting normal cells. Research indicates that taking a statin drug (for cholesterol) during chemotherapy and radiation treatment could lead to better responses to treatment as well as fewer side effects.
Research indicates that taking a statin drug, used to regulate cholesterol levels, can lead to better patient responses to chemotherapy and radiotherapy in rectal cancer. This is a randomised study which aims to recruit 222 patients from Australia and New Zealand. The trial is led by Principal Investigators Professor Steve Ackland and Associate Professor Michael Jameson.
Half of the patients will be randomly allocated to receive 40mg of the statin drug simvastatin for 90 days prior to their first radiation dose for standard chemo-radiotherapy. The other half of patients will be allocated to receive a placebo.
Not only do researchers hope that statin drugs will improve the effect that chemoradiation has on tumours, as well as reducing radiation toxicity to the skin and gastrointestinal tract. In this way, statins have the potential to improve both survival outcomes for patients and their quality of life.
If the results of SPAR are positive, this will lead to a phase III trial, a large-scale trial that would aim to confirm the findings. This would then in turn change the standard of care through the routine addition of statins to chemoradiation for rectal cancer.
“A positive outcome in the SPAR trial, either through improved tumour response or reduced toxicity from chemoradiation, would lead to a phase III trial to confirm these findings and look at long-term outcomes,” says Associate Professor Jameson. “This could change the worldwide standard treatment for rectal cancer to giving a statin with chemoradiation.”
This trial has opened in two sites, and the first patient has been recruited and randomised for treatment. If you think this trial could be relevant to your situation, or would like more information, visit the trial information page.