AGITG clinical trials:    GAP

This trial aims to evaluate the impact pre-operative chemotherapy in pancreatic cancer has in increasing the quality of the surgery to remove the pancreatic cancer.   For surgery in pancreatic cancer to be considered successful there needs to be no cancer left over after surgery, this is often hard to achieve due to the way the cancer grows into vital structures. It will also assess treatment-related toxicity and treatment failure.

Over 2700 Australians are diagnosed with pancreatic cancer each year, making research in this disease a high priority. The five-year survival of patients undergoing surgery is still low at 20%, despite improvements in surgical care and the addition of therapies after surgery. Recurrence of the cancer is a frequent problem — and different therapies are being investigated to counter this.

Recent research suggests that the combination of gemcitabine and Abraxane (nab-paclitaxel) brings significant improvement in response and overall survival in the metastatic setting. Therapy before surgery therapy is able to identify patients with aggressive tumour biology who may be spared the effects of resection surgery, while also identifying patients most likely to benefit from radical therapy.

Cancer type:    
Trial status:    In follow-up
For more information: click here for summary.

AGITG clinical trials:

UPDATE: Recruitment for this trial has been TEMPORARILY SUSPENDED.

ACTICCA-1  is an international multi-centre trial led by the German groups AIO/DGAV/DGVS and coordinated by the University Cancer Centre in Hamburg, Germany.

This randomised, multidisciplinary phase III trial is looking at cholangiocarcinoma – a type of cancer that develops in the bile ducts.   The bile ducts carry bile from the liver and gallbladder through the pancreas to the small intestine.   Bile is a dark-green or yellowish-brown fluid secreted by the liver to digest fats and helps rid the liver of waste products. This type of cancer is rare, with only a few hundred cases in Australia and it occurs more frequently in the older population.

There are many unanswered questions about the best way to treat this cancer.   If it has remained within the bile ducts, not spread elsewhere, the best treatment is to remove all the cancer with surgery.   This is sometimes possible, but in some cases the cancer comes back. In some other types of cancer, giving extra treatment with chemotherapy after surgery has helped — but there’s no definite trial evidence at the moment to show if this is true for cholangiocarcinoma.   So there’s a need for a comparison study to help improve the survival for people with this cancer.

ACTICCA-1 will help us find the best way to treat people with cholangiocarcinoma after their surgery — and particularly whether using chemotherapy helps. The chemotherapy drugs used in this trial, gemcitabine and cisplatin, are often used to treat advanced cholangiocarcinoma and are widely used in oncology practice.

This trial will help us know if giving chemotherapy after surgery increases the chance of the cancer not coming back. It will monitor people to see how often their cancer comes back, whether this happens less often when chemotherapy is used – and any side-effects from the treatment, quality of life and complications from surgery, amongst other things.

Cancer type:      Bile duct                                    
Trial status:
   In  follow-up
For more information:  click here for summary.

AGITG clinical trials: TACTIC

This study aims to evaluate the safety and efficacy of combining panitumumab with the standard cisplatin and gemcitabine treatment for advanced biliary tract cancer.

The patient population that may participate in this trial would routinely be treated with a combination of the chemotherapy drugs gemcitabine and cisplatin. Participants in this study will additionally receive panitumumab; so that the outcomes associated with treatment using the 3 drugs together can be evaluated.

Participants will be monitored closely for side effects (toxicity) and for tumour response to treatment. Treatment will continue until disease progression, unacceptable toxicity, investigator discretion or patient request to cease. Once off study treatment, participants will be followed up for 30 days, then every 12 weeks until disease progression or commencement of new treatment, then according to best practice until death.

Data from this trial will inform us about how safe and tolerable the treatment is, and we will make some comparisons to other trials of chemotherapy alone for this disease. If positive, this study may lead to improved treatment for patients with biliary tract cancer. If negative, it will still give information regarding the biology of the disease, including the incidence of KRAS mutation in this tumour type.

Cancer type:  Biliary tract
Trial status:  In follow-up
For more information: click here for summary

AGITG clinical trials:

CONTROL NETS will assess which treatment is most promising — chemotherapy alone, radiopeptide therapy or the combination – in improving disease control in patients with advanced neuroendocrine tumours (NETs).

These are rare cancers that can develop in different locations throughout the body, including the gastrointestinal tract and the pancreas.   These relatively rare tumours are rising in incidence and due to the relatively long patient survival have a much higher prevalence, second only to colorectal cancer.

Modern randomised controlled trials have confirmed the efficacy of two unrelated, relatively expensive therapies. Peptide receptor radionuclide therapy (PRRT) and chemotherapy with capecitabine (CAP) and temozolomide (TEM) either in combination or individually, have shown very promising activity in initial trials.

This trial presents a unique opportunity for Australian and New Zealand centres to lead the world in the development of high-quality evidence to guide the management of NETs.  Finding the treatment that is most promising would then allow it to be investigated further in a larger randomised trial comparing it with standard treatment, in order to guide best practice.

Cancer type:    
Neuroendocrine tumours (NETs)
Trial status:
  Open to patient participation          
  The trial will seek patients with advanced NETs.
For more information: click here for summary.

AGITG clinical trials: NABNEC

The aim of the study is to assess which treatment is most promising — carboplatin and etoposide chemotherapy, or carboplatin and paclitaxel chemotherapy, in improving disease response rates in patients with advanced Neuroendocrine Carcinomas (NECs). Finding the treatment that is most promising would then allow it to be investigated further in order to guide best practice. The trial will also look at outcomes of survival, monitor the side effects of treatment, identify useful markers of prognosis and response, and increase our understanding of the biology of NECs.

NABNEC was funded by an NHMRC Project Grant from 2016-2020 and ethics approval was obtained in March 2016.   Sites have been selected, and the agreement with Specialised Therapeutics Australia for provision of an additional payment per patient and supply of nab-paclitaxel was executed in August. The study opened to recruitment in September.

Cancer type:     Neuroendocrine Carcinomas (NECs)
Trial status:
  Open to patient participation          
  The trial will seek patients with advanced  NECs
For more information:



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