SPAR

Protocol Title

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

Purpose of the Study

The SPAR trial aims to build on research that indicates that a statin drug, taken for cholesterol, can lead to better patient responses to chemotherapy and radiotherapy in rectal cancer. The SPAR trial compares Simvastatin to no Simvastatin, in addition to standard chemotherapy and radiotherapy, in preoperative chemoradiation (pCRT) treatment for patients with rectal cancer.

Eligibility Criteria

Inclusion Criteria

1. Males or females with biopsy proven rectal adenocarcinoma, or high-grade dysplasia with radiological evidence of invasive tumour
2. Distal border of the tumour is below the peritoneal reflection as assessed by MRI scan
3. Age more than or equal to 18 years
4. Clinical TNM tumour staging is T2-4 N0-2 M0 after staging investigations including CT scan of chest, abdomen and pelvis and pelvic MRI scan
5. Planned for concurrent long-course pCRT using fluoropyrimidine-based chemotherapy
6. Radiologically-measureable disease on baseline pelvic MRI scan
7. Adequate bone marrow function
8. Adequate liver function
9. Adequate renal function
10. Trial treatment planned to start within 28 days of randomisation
11. Diagnostic biopsy of rectal tumour is available for histological substudies
12. Willing and able to comply with all trial requirements, including treatment, timing and/or nature of required assessments
13. Signed, written informed consent for the main trial

Exclusion Criteria

1. Contraindications or hypersensitivity to statins, fluoropyrimidine chemotherapy or radiotherapy
2. Patients planned to receive oxaliplatin or biological agents (e.g. cetuximab) as part of pCRT
3. Taking statins in the 6 weeks before planned start of pCRT
4. Predicted life expectancy of less than 3 years
5. Prior pelvic or rectal radiotherapy
6. History of another malignancy within 5 years prior to registration.
7. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
9. Pregnancy, lactation, or inadequate contraception.

Contact Email

spar.study@sydney.edu.au

More Information Available on

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

STUDY CHAIRS

Associate Professor Michael Jameson
Professor Stephen Ackland

Funding

Cancer Society of New Zealand
CCNSW
Cancer Australia

Patients Recruited

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

Open Trial Recruitment Table