Open / Translational Research Studies
If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.
Predicting ChemoRadiotherapy Sensitivity in Rectal Cancer Organoids (PRoSecCO)
Purpose of the Study
Bowel cancer is the third most commonly diagnosed cancer in Australia and is a leading cause of cancer related death. Rectal cancers are located in the lower region of the bowel and account for over one-third of all bowel cancers. Standard treatment for locally advanced rectal cancer is chemotherapy plus radiotherapy (chemoradiotherapy). Approximately 20-30% of these patients respond very well to this therapy, but a significant proportion of patients do not receive benefit and often endure harmful side-effects. Personalisation of patient treatments based on prediction of therapy response could improve patient management. Identification of patients likely to have successful ablation of their cancer by chemoradiotherapy could mean surgery can be avoided, whilst identification of patients unlikely to respond could mean that potentially harmful radiation is avoided and alternative therapeutic approaches could be provided earlier.
It has recently become possible to grow individual patient’s cancer cells in the laboratory. These 3-dimensional models faithfully mimic the biology of the original cancer and are called ‘organoids’. The development of patient-derived organoid models has transformed the study of cancer biology. Laboratory based drug testing of these organoids has been shown to predict clinical response to therapy. In this study, we plan to test the feasibility of collecting biopsy tissue from patients with locally advanced rectal cancer, growing this tissue in the laboratory and testing the sensitivity of the cells to chemoradiotherapy. We will then compare the outcome of our laboratory findings with the clinical response in the patient. This will be the first study of its kind in Australia. If we are able to consistently establish organoid models and test chemoradiotherapy sensitivity in a rapid timeframe, this will pave the way for a future clinical trial where the choice of patient therapy is made based on this laboratory test. We hope that the increased use of this personalised approach to therapy will ultimately improve patient outcomes by accelerating access to therapies most likely to provide benefit, whilst limiting procedures and therapies that may produce adverse effects in the absence of benefit.
Professor Vicki Whitehall
Please contact Dr Sarah Hayes (email@example.com) if you have questions regarding this study.
2022 AGITG Rectal Cancer Research Grant
Open / Translational Research Studies
If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.
A randomized, placebo-controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer
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.
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.
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Associate Professor Michael Jameson and Professor Stephen Ackland
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Funded by Cancer Society of New Zealand / CCNSW/Cancer Australia