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 GICI considers funding. When medical specialists and other health researchers submit clinical research, trial and fellowship funding proposals to GICI, 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 GICI 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

Current GICI Supported Research

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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”  GICI has awarded Dr Kemp and her team $50,000 for this valuable Clinical Research.

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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” GICI has awarded Dr Purcell and her team $50,000 for this valuable Clinical Research with the support of the Hugh Green Foundation.

Current Clinical Trials

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INTEGRATE II 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 – Auckland Hospital – GICI 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.

SCOT (Short Course Oncology Therapy) Trial

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. The early 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. However, the patients need much longer follow-up to establish whether recurrence rates and survival are the same for 12 compared with 24 weeks of treatment, and also check for persisting long term nerve side effects.

A La CaRT (Australasian Laparoscopic Cancer of the Rectum Trial) Trial

GICI 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 trial – lay summary and update 20 July 2015

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 Gastro-Intestinal Cancer Institute (GICI) of New Zealand and a Research Project Grant from Genesis Oncology Trust, awarded to the Principal Investigator for Auckland City Hospital, Dr Maria Pearse. or more information on clinical trials, see Research & Clinical Trials To help us continue to support clinical research, Donate Now.

 

Awareness Campaign each April

#LoveYerGuts

Crunch Day May 5th each year

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This year we launched our #LoveYerGuts  and raised $38,250. Can you do 50 gut crunches in 5 minutes and raise funds for gut cancer.  For more information click here.

Thanks to the support of the Hugh Green Foundation and JM Thompson Trust.

Education

Education sessions can be provided on request. We cover gastro-intestinal cancer symptoms, latest statistics, treatments and clinical trials as well as prevention. We can tailor to your needs!

Contact: info@gicinz.org.nz or 0800 112 775

Symptoms of GI Cancers

Bowel Cancer

Bleeding from the bottom (rectal bleeding) without any obvious reason.

Or if you have other symptoms such as straining, soreness, lumps and itchiness.

A persistent change in bowel habit going to the toilet more often or experiencing looser stools for several weeks

Abdominal pain especially if severe

Any lumps or mass in your tummy

Weight loss and tiredness (a symptom of anaemia)

Source:  www.beatbowelcancer.org.nz/learn/symptoms/

 

Upper GI Cancers

 Oesophagus: Difficulty swallowing and weight loss

 Stomach: Indigestion, early fullness after eating, loss of appetite, unexplained weight loss, blood loss, and pain

 Liver: Jaundice (yellowing of the skin and eyes), abdominal swelling, loss of appetite, pain, and weight loss

 Gallbladder cancer does not usually cause symptoms until it becomes more advanced.

 Pancreas: This cancer often causes obstruction of the lower end of the bile duct (which goes though the head of the pancreas), which causes jaundice, itchiness and pale coloured stools. Other symptoms include loss of appetite, weight loss, back pain, and fatigue.