SPAR
  • SPAR
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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 placebo, 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@ctc.usyd.edu.au

Principal Investigator

Associate Professor Michael Jameson
Professor Stephen Ackland

More Information Available on

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

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

Participating Centres

New South Wales
Lake Macquarie Private Hospital
Royal North Shore Hospital
Chris O’Brien Lifehouse
Bankstown-Lidcombe Hospital
Calvary Mater- Newcastle
Port Macquarie Base Hospital/NCCI
Queensland
Icon Cancer Centre Gold Coast University Hospital
Mater Hospital Brisbane
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Victoria
Peter MacCallum Cancer Centre
New Zealand
Christchurch Hospital
Palmerston Hospital
Waikato Hospital
Tauranga Hospital

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:

Open Trial Recruitment Table

Participating Centres

New South Wales
Lake Macquarie Private Hospital
Royal North Shore Hospital
Chris O’Brien Lifehouse
Bankstown-Lidcombe Hospital
Calvary Mater- Newcastle
Port Macquarie Base Hospital/NCCI
Queensland
Icon Cancer Centre Gold Coast University Hospital
Mater Hospital Brisbane
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Victoria
Peter MacCallum Cancer Centre
New Zealand
Christchurch Hospital
Palmerston Hospital
Waikato Hospital
Tauranga Hospital

Study Chairs

Associate Professor Michael Jameson and Professor Stephen Ackland

Contact Email

spar@ctc.usyd.edu.au

More Information

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

Funding

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