Supporting clinical research, trials and fellowships
The funds we raise are given in grants to institutions in New Zealand that are running clinical research, trials and fellowships that our experts believe will have a significant impact on improving treatments for patients with gastro-intestinal cancer.
Who are our experts and how do we select which trials to fund?
Our Scientific Advisory Committee (SAC) undertakes the critical review of clinical research, trials and fellowships which GCF considers funding. When medical specialists and other health researchers submit clinical research, trial and fellowship funding proposals to GCF, SAC reviews the importance of the question posed in the trial, the design of the trial, and the ability of the trial to yield results that will have a positive impact on cancer treatments. SAC makes recommendations to the GCF Board of Directors who have the final vote. They approve a sum for the institution running the research, trial and fellowship based on its costs and benefits.
From there, the Principal Investigator (the doctor running the research or trial) or the Fellow seeks approval to conduct the research or trial from the institution’s health research ethics committee. The doctor’s team sets up the infrastructure to run the research or trial and recruit patients who meet the criteria. They monitor the patients, and document, analyse and evaluate the results. Many research projects and trials are performed in collaboration with colleagues in Australia, or other countries. Finally, the results are published in medical journals to help guide specialists to make the best treatment decisions. For more information about clinical research and trials go to Lancet oncol Jan 15 e32
Every year GCF runs an annual Awareness Campaign called ‘LoveYerGuts’. We ask people to wear orange, rattle buckets or do 14 gut crunches a day in May until LoveYerGuts Day on May 31st.
The aim is to increase awareness of the high rates of GI or gut cancers such as the oesophagus, stomach, liver, pancreas, gallbladder, bowel and rectum. Over 5,000 people are told each year they have one of these cancers and the upper GI cancers have a very low 20% survival rate over 5 years. Lower GI cancers have a 66% survival rate over 5 years if caught early.
That is 14 people a day are told they have a GI cancer and 8 people will die each day!
These cancers are the highest rates as a group of cancers and a higher death rate than breast and prostate cancers combined. But we don’t hear enough about them! Help us raise vital funds while raising awareness by clicking here.
- Clinical trials
GCF has funded Dr Amanda Ashley and her team at Auckland Hospital,three patients to go onto this valuable trial to the value of $23,741.
ACTICCA-1 is a randomised, controlled, two stage, multicentre Phase III trial comparing gemcitabine+ cisplatin with standard of care (capecitabine) after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma. Cholangiocarcinoma is diagnosed in approximately 80 people every year in New Zealand. In half of these people curative intent treatment with surgery is possible. Following this surgery however, only 20-30% of people survive 5 years. This long term survival can be increase by giving chemotherapy after the surgery and the current standard is capecitabine. In this trial patients will receive either cisplatin and gemcitabine or capecitabine alone following their surgery. The aim is to find out if giving cisplatin and gemcitabine can improve the outcomes for these patients.
INTEGRATE 2 is a Randomised Phase III Double-Blind Placebo-Controlled Study of regorafenib in Advanced Gastro-Oesophageal Cancer (AGOC) which will be conducted in Australia, New Zealand, Korea, Japan, Taiwan, Canada and the USA. There currently exist few effective treatment options for patients with Advanced Gastro-Oesophageal Cancer (AGOC) that has returned after surgery or where it is incurable (metastatic) at diagnosis. Chemotherapy can be effective at first, but once the cancer has become resistant to it, the options for treatment are limited. A second course of a different chemotherapy can prolong survival, but not all patients are fit to receive this treatment. For those who do receive a second course, their cancer will eventually become resistant to these drugs. In both of these situations, there are currently no accepted treatment options that have been shown to be both effective against the cancer and tolerable for patients. Better treatment options are urgently needed. Regorafenib is a ‘multi-targeted therapy’ targeting a number of different signals in the cancer cell that cause it to grow and produce blood vessels. In other cancers such as colon cancer, Regorafenib has been proven to be of benefit when other drugs have ceased to work. INTEGRATE demonstrated efficacy with the use of Regorafenib in advanced Gastro-Oesophageal Cancer, and could potentially become a new standard of care after other therapeutic agents have stopped working. INTEGRATE II is being undertaken to confirm the findings of the Phase II trial in a larger population. If the study is positive it will provide evidence for Regorafenib as a new standard of care after other treatments no longer benefit patients with gastric cancer.Worldwide 350 oatients– Auckland Hospital – GCF has agreed to fund 3 patients over 2 years funded at a cost of $8852 for all three. This supports recruitment for radiology and laboratory requirements only.
Circulating Tumour DNA as a Biomarker Pancreatic Cancer
Pancreatic cancer is a devastating cancer with a very poor outlook. The only chance of cure is early diagnosis leading to early surgical resection. Unfortunately this is rare, because by the time of diagnosis, the cancer is usually not resectable. Therefore, we need a tool to diagnose this cancer earlier. Cancers are caused by gene mutations in the DNA inside each cancer cell. We can detect the mutated DNA floating in normal blood. Because the normal DNA in blood has very few mutations, the presence of specific mutated DNA can signal the presence of a cancer.
This study aims to test whether this mutated DNA can be detected in the blood of patients with pancreas cancer. It may therefore become a useful diagnostic test. This might lead to being able to diagnose the cancer earlier while it is still resectable. This may increase cure rates. The Study: Professor Peter Gibbs is one of three investigators leading this translational clinical study coordinated from the Translational Oncology Group at the Walter and Eliza Hall Institute in Melbourne. This is a collaborative project across several Australian sites. Auckland has been asked to join as the only New Zealand site. Participation in this study will build an excellent collaborative relationship between Auckland and Melbourne. Patients who are undergoing surgery for pancreatic cancer (Stage 1 or 2) will have a blood test before and after surgery. This is the only requirement for patients. They would otherwise have standard workup and clinical follow up. The blood samples will be sent to Melbourne for analysis. DNA and RNA will be extracted from the blood, and searched for mutations. Presence or absence of mutations before and after surgery will then be compared to relapse and survival. Key researcher in Auckland is Dr Ben Lawrence and the Department of Oncology.
This international trial with 119 participants, concluded that ctDNA has promise for a screening test for pancreas cancer, and for predicting relapse in people with pancreas cancer. It is now closed and outcomes were presented at ASCO (American Society Conference of Onclologists).
SCOT (Short Course Oncology Therapy) Trial
This trial is now closed and results are below.
Patients who are diagnosed with early bowel cancer may be advised to have chemotherapy treatment for 24 weeks after surgery. This treatment increases their chances of surviving the cancer. Unfortunately, all chemotherapy treatments have side effects and these side effects often get worse as the treatment goes on. Previous studies have demonstrated that a shorter course of chemotherapy may be less toxic without being less effective. The aim of the SCOT trial is to definitively answer the question of whether 12 weeks of chemotherapy is as effective in reducing cancer recurrence as the current standard practice of 24 weeks of the same chemotherapy drugs. It is hoped that the 12 week chemotherapy treatment will not only show less side effects than the 24 week treatment, and would be much more convenient, but also would be no less effective. New Zealand patients joined others from around the world, and were randomly assigned to have their treatment for 12 or 24 weeks. Results have been released and show side effects, such as nerve damage, were less for those patients receiving 12 weeks of chemotherapy compared to those receiving 24 weeks. Despite the fact the international study was underpowered, the data suggested that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care.
A La CaRT (Australasian Laparoscopic Cancer of the Rectum Trial) Trial
This trial is now closed and results are below.
GCF was pleased to be able to support New Zealand participation in the Australasian Laparoscopic Cancer of the Rectum Trial (ALaCaRT), which compared laparoscopic assisted (or keyhole surgery) with conventional open surgery for the treatment of rectal cancer. The study enrolled 475 patients from Australia and New Zealand and recently reported the preliminary findings based on an assessment of the adequacy or completeness of removal of the cancer. JAMA October 2015 article click here. Patients were randomly allocated to either laparoscopic or open surgery with the aim of finding out whether or not laparoscopic surgery was as effective as open surgery at removing the cancer. They found that rates of complete tumour removal, as assessed by pathological examination of the removed specimen, were excellent overall, but lower after laparoscopic than open surgery. The study therefore was not able to prove that laparoscopic surgery was as good as open surgery at obtaining complete tumour removal.
At first impression this may seem like a disappointing result, but there several important messages that we can take from the ALaCaRT trial. The first is that the quality of surgery overall, including the laparoscopic group, was found to be excellent by international standards and this is a common feature of well designed clinical trials; participants tend to receive a very high standard of care. The second message is the importance of clinical trials in determining the role of new treatments, whether these are new drugs or new ways of performing operations. Patients in the ALaCaRT study will continue to be followed up to determine rates of cancer recurrence and long term survival.
TOPGEAR is an international, multi-centre, randomised, phase II/phase III clinical trial which is investigating whether the addition of radiation treatment to chemotherapy before a patient’s surgery can improve outcomes such as pathological complete response rates and overall survival. More than 50 centres across New Zealand, Australia, Canada and Europe are participating in this trial. All participants will receive chemotherapy and will be randomly allocated to one of two treatment groups:
● preoperative chemotherapy followed by postoperative chemotherapy
● OR preoperative chemo-radiation followed by postoperative chemotherapy
Participants will be seen frequently while on treatment, at least 3 weekly while on chemotherapy or chemo-radiation. Follow up will be every 3 months during year 1 and then every 6 months until 5 years. Phase II of the trial enrolled 120 participants and is now complete, and in early 2015, a planned analysis of data from these 120 participants was performed. This analysis confirmed that the trial treatment posed no concerns from a safety perspective and the study should continue. TOPGEAR is now recruiting into the phase III component and intends to recruit a total of 632 patients, including the phase II participants. As of May this year, more than 179 participants have been recruited internationally to the TOPGEAR study. Auckland City Hospital, Christchurch Hospital, Dunedin Hospital and Waikato Hospital have taken part in and contributed to the TOPGEAR study in the phase II component. Auckland City Hospital is continuing to recruit patients to the phase III part of the TOPGEAR trial and aims to enrol another 4 participants onto this study in the next 2 years. This continuation for phase III of the study in Auckland is generously supported by funding from the Gut Cancer Foundation (GCF) and a Research Project Grant from Genesis Oncology Trust, awarded to the Principal Investigator for Auckland City Hospital, Dr Maria Pearse.
The interim phase II feasibility and safety results were published in the Annals of Surgical Oncology, these results showed that pre-operative chemoradiation is safe and feasible and does not adversely affect surgical morbidity. You can view the published article in its entirety by clicking here.
Australasian GI Cancer Trials Group (AGITG)
Current trials of interest only open in Australia.
The MONARCC trial has now opened to recruitment - this trial looks at the best treatments for elderly patients with colorectal cancer. These patients often cannot tolerate standard chemotherapy treatments.
The SPAR trial investigating rectal cancer has also opened and recruited its first patient. The trial is researching the potential of statin drugs, usually used for cholesterol, for increasing the effectiveness of chemotherapy. The LIBERATE study has opened, which is studying the use of blood tests to detect the presence of tumours earlier than current screening methods.
For more information on AGITG trials and research go to www.gicancer.org.au
- Clinical research
Current GCF Supported Research
GCF has funded Dr Nuala Helsby and her team at the University of Auckland, a year’s part time salary for a clinical trial manager to support the following research.
THYmine2 is an observational study to assess whether the thymine loading test can prospectively categorise patients who cannot tolerate 5-FU treatment (e.g. FOLFOX, CapeOx, FLOX). This treatment is commonly used in GI and breast cancer treatment. Reactions occur in approximately 10% of patients and can result in life threatening events. Despite extensive research it is still difficult to determine who is at risk of life-threatening toxicity related to 5-FU. This study aims to examine whether the ratio of thymine to its metabolite in urine can discriminate between patients who tolerate 5-FU and those who experience severe 5-FU related toxicity. If successful then it could be a simple and inexpensive way to identify susceptible patients before they start treatment and allow for dose adjustments or alternative treatment. This is partly funded by the David Levene Foundation.
Professor Peter Shepherd and Dr Khanh Tran, Auckland Cancer Society Research Centre and the Department of Molecular Medicine at the University of Auckland
Professor Peter Shepherd and his team at the University of Auckland, have been awarded $50,000 for a second year to study a form of colorectal cancer which is difficult to treat normally. A drug combination used to treat melonoma will be trialed in the laboratory as a pre-clinical experiment to determine if there is any tumour response using the drugs vemurafenib and axitinib. This funding is thanks to the Ted and Mollie Carr Fund and Estate of Ernest Davis through Perpetual Guardian.
Dr Roslyn Kemp, Department of Microbiology and Immunology, University of Otago.
"In colorectal cancer, a strong immune response within the tumour is associated with a good outcome for patients. We will validate this finding, for the first time, in New Zealand patients. We will also use a new technology to characterize these immune cells to determine their mechanisms of action" GCF has awarded Dr Kemp and her team $50,000 for this valuable Clinical Research. Funding for this research has been completed and we await outcomes as the research is completed and published.
Dr Rachel Purcell, University of Otago.
"New Zealand has one of the highest rates of colorectal cancer (CRC) in the world. We aim to classify CRC using gene-expression profiles in order to improve treatment strategies and outcomes. We will also study CRC microbiomes to determine the role of bacteria in the development of CRC subtypes" GCF has awarded Dr Purcell and her team $50,000 for this valuable Clinical Research with the support of the Hugh Green Foundation. Funding for this research has been completed.
Outcomes include the following:
CMS1 is associated with right-sided tumours in females, node negative and poorly differentiated tumours. CMS2 tumours were predominantly left-sided and in male patients. CMS4 were more often found in younger patients, those with rectal tumours and higher stage. Interestingly, we did not find any prognostic benefit of stratifying tumours using CMS, in contrast to the published literature on CMS. In our treatment-naïve cohort, TNM remains the most useful method of tumour stratification. A manuscript has been prepared detailing these findings and submitted for publication.
- Clinical trial applications
- Clinical research and fellowships available
Subject title: GCF: Call for Applications – Part time 0.3-0.5 FTE GI Cancer Clinical Research Fellowship or Clinical Research Project in the Auckland region only
The Gut Cancer Foundation is calling for applications for:
Part time GI Cancer Clinical Fellowship or Clinical Research
The Gut Cancer Foundation offers one part time 0.3-0.5 FTE GI Cancer Clinical Research Fellowship award each year for three years supported by Ted and Mollie Carr through Perpetual Guardian. The Fellowship is for the support of outstanding graduates working in the Auckland region from all relevant health professions, who are able to combine their clinical work with research to improve the quality of life and potential survival for people living with a GI cancer.
The Fellowship is tenable for a period of up to three years. Applications are open to appropriately qualified individuals with New Zealand residency, permanent residency or citizenship, who hold a relevant degree or are in the process of completing their training.
The GI Cancer Clinical Fellowship would be available in (but not limited to) the speciality areas of cancer surgery, radiation oncology, medical oncology, palliative care, cancer genetics, radiology, anatomical pathology, nutrition, psychiatry or public health.
The salary will be the equivalent to the appropriate level of remuneration of the applicant’s current employment. Please provide evidence of your current salary per annum. The Foundation will provide a contribution towards working expenses of $5,000 per annum. The Foundation has a total of $45,000 per annum for remuneration of salary costs only.
Clinical Research Project
This application can also be in the form of a GI Cancer Clinical Research project to the value of $50,000 (GST excl) annually in the Auckland region. This can be one project annually or for up to three years at a total value of $150,000 (GST excl) paid in annual instalments of $50,000 (GST excl). The criteria for applicants are the same as for the Fellowship including the requirement that the research is conducted in the Auckland region.
All recipients would be expected and required to acknowledge funding support from GCF and the Ted and Mollie Carr fund through Perpetual Guardian, in oral or written reports about their work. The successful applicant must be prepared to have a profile posted on GCF’s website www.gutcancer.org.nz and promoted through GCF’s marketing material. Six monthly progress reports are required using the provided accountability template.
Applications should be made on the Research Proposal form attached and needs to include the proposed research, and also information about the applicant, description of how his/her time will be allocated, and demonstration of value to their career.
Applications forms are below and must be received by GCF NZ by email to firstname.lastname@example.org by 5 pm, 1st March 2019. Please note that your host institution may have an earlier closing date and GCF strongly encourages you to adhere to the internal deadline. Please also ensure that you also fulfil any institutional requirements for submission.
The decision will be made by GCF’s Scientific Advisory Committee and ratified by the Gut Cancer Foundation board of directors. Applicants will be notified by of the final decision by 1st April 2019.