
- SPAR
Trial Status
Open
Cancer Type
Rectal Cancer
If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.
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
- Males or females with biopsy proven rectal adenocarcinoma, or high-grade dysplasia with radiological evidence of invasive tumour
- Distal border of the tumour is below the peritoneal reflection as assessed by MRI scan
- Age more than or equal to 18 years
- 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
- Planned for concurrent long-course pCRT using fluoropyrimidine-based chemotherapy
- Radiologically-measureable disease on baseline pelvic MRI scan
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Trial treatment planned to start within 28 days of randomisation
- Diagnostic biopsy of rectal tumour is available for histological substudies
- Willing and able to comply with all trial requirements, including treatment, timing and/or nature of required assessments
- Signed, written informed consent for the main trial
Exclusion Criteria
- Contraindications or hypersensitivity to statins, fluoropyrimidine chemotherapy or radiotherapy
- Patients planned to receive oxaliplatin or biological agents (e.g. cetuximab) as part of pCRT
- Taking statins in the 6 weeks before planned start of pCRT
- Predicted life expectancy of less than 3 years
- Prior pelvic or rectal radiotherapy
- History of another malignancy within 5 years prior to registration.
- Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- Pregnancy, lactation, or inadequate contraception.
Contact Email
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:
Participating Centres
Trial Status
Open
Cancer Type
Rectal 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:
Participating Centres
Study Chairs
Associate Professor Michael Jameson and Professor Stephen Ackland
Contact Email
spar@ctc.usyd.edu.auMore Information
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Funding
Funded by Cancer Society of New Zealand / CCNSW/Cancer Australia