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Closed (no longer recruiting)Last updated: 13 February 2024

SPAR: This phase 2 trial is assessing the clinical benefit of adding a statin (Simvastatin) to standard chemotherapy and radiotherapy to treat patients with rectal cancer before surgeryA randomized, placebo-controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer

Clinical summary

Summary

Patients eligible to participate in this trial will receive daily oral doses of Simvastatin or a placebo, which will be taken for 90 days and commenced 1 week prior to the first radiation dose.

Conditions

This trial is treating patients with Rectum Cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

SPAR

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Cancer Council NSW, Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

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

Eligibility

Inclusion

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 (e.g. platelets >100 x 109/L, neutrophils >1.5 x 109/L)
8. Adequate liver function (e.g. ALT/AST <3 x ULN, bilirubin <1.5 x ULN)
9. Adequate renal function (e.g. estimated creatinine clearance >50 ml/min)
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 (e.g. able to swallow tablets), timing and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments)
13. Signed, written informed consent for the main trial

Exclusion

 

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. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment
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. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.


Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.