SPAR

This randomised phase II trial aims to evaluate the effect of simvastatin (SIM) on efficacy and toxicity of pCRT in rectal cancer patients, and on systemic and local inflammatory responses.

Rectal cancer is often treated by chemotherapy and radiation before surgery but if the cancer responds poorly many patients relapse.  This randomised phase II trial aims to evaluate the effect of simvastatin (SIM) on efficacy and toxicity of pCRT in rectal cancer patients, and on systemic and local inflammatory responses.

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Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Aim

This randomised phase II trial aims to evaluate the effect of simvastatin (SIM) on efficacy and toxicity of pCRT in rectal cancer patients, and on systemic and local inflammatory responses.

Summary

Rectal cancer is often treated by chemotherapy and radiation before surgery but if the cancer responds poorly many patients relapse. Retrospective studies show better cancer responses and fewer side effects in patients taking a statin drug (for cholesterol) during radiation. This study with 222 Australasian patients will test if taking a statin for 3 months (during combined chemotherapy and radiation then for another 6 weeks) improves the rate of good tumour response and reduces side effects of this treatment.

Participating Centres

New South Wales
Lake Macquarie Private Hospital
Bankstown-Lidcombe Hospital
South Australia
Queen Elizabeth Hospital
New Zealand
Waikato Hospital

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol Title

A randomized, placebo-controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer

Aim

This randomised phase II trial aims to evaluate the effect of simvastatin (SIM) on efficacy and toxicity of pCRT in rectal cancer patients, and on systemic and local inflammatory responses.

Background

Retrospective studies have shown improved outcomes in colorectal cancer (CRC) patients if taking statins, including overall survival, pathological response of rectal cancer to preoperative chemoradiotherapy (pCRT), and acute and late toxicities of pelvic radiation. Major tumour regression following pCRT has strong prognostic significance and can be assessed in vivo using MRI-based tumour regression grading (mrTRG) or after surgery using pathological tumour regression grading (pathTRG).

Clinical Trial Design

This is a Randomised double-blind placebo-controlled multicentre phase II trial. 222 patients, recruited from New Zealand and Australian sites over 3 years, will be centrally randomised through the NHMRC CTC.

Treatment allocation will be balanced using minimisation for major prognostic variables. Patients will be allocated in a ratio of 1:1 to SIM or placebo.

Patients Recruited

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

New South Wales
Lake Macquarie Private Hospital
Bankstown-Lidcombe Hospital
South Australia
Queen Elizabeth Hospital
New Zealand
Waikato Hospital

Study Chairs

Associate Professor Michael Jameson and Professor Stephen Ackland

Contact Email

spar@ctc.usyd.edu.au

More Information

Detailed information will be available shortly on: Australian and New Zealand Clinical Trials Registry

Funding

Funded by Cancer Society of New Zealand / CCNSW/Cancer Australia