AGITG clinical trials:  DOCTOR

DOCTOR is a Randomised Phase II Trial of Pre-operative cisplatin, 5 fluorouracil and docetaxel with or without Radiotherapy in patients whose oesophageal cancer (including gastro-oesophageal junction) has not responded well to standard chemotherapy.

This study is breaking new ground in pre-operative therapy for oesophageal cancer. It’s the first to focus on changing the therapy for metabolic non-responders to pre-operative therapy to try to improve response and potentially survival. It’s also innovative in other ways — such as assessing whether changing therapy can salvage a response. It will provide valuable data regarding the potential to individualise therapy related to the tumour characteristics — so-called “tailored therapy”.

Over the last 30 years, the incidence of oesophageal cancer in Australia has increased more than any other cancer. Surgery forms the mainstay of curative treatment — but survival remains poor. Preoperative chemotherapy with or without concurrent radiotherapy have resulted in modest improvements in outcome.

Increasing the proportion of responders to pre-operative therapy remains one of the major challenges facing patients with localised oesophageal cancer.

Cancer type:  
Trial status:  In follow-up
Eligibility:   The trial is seeking to recruit patients whose oesophageal cancer has not responded to the standard pre-op chemotherapy treatment.
For more information: click here for summary.  

AGITG clinical trials:

This trial on stomach cancer aims to investigate whether the addition of chemoradiotherapy (chemotherapy + radiotherapy) is superior to chemotherapy alone in first-line treatment, in terms of overall survival for patients who can undergo appropriate surgery.

Stomach cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer.

Although the survival rates for patients with early stage disease are good, this subgroup of patients constitutes only 20% of those undergoing rsurgery. Most patients will have locally advanced or metastatic disease at first presentation – with an extremely poor prognosis. The five-year survival rate for stomach cancer in Australia is 27% – this has improved only slightly over the past forty years. Despite this, there have been several important recent advances using chemotherapy and radiotherapy after surgery, generating new interest and debate on best treatment of resectable gastric cancer.

Opinions remain divided whether chemoradiotherapy is superior to chemotherapy alone in treatment of stomach cancer after surgery – clinical practice varies amongst different institutions.

Cancer type:    
Gastric (stomach)
Trial status:    Open to patient participation
Eligibility:   The trial is seeking to recruit patients whose stomach cancer is suitable for surgery to remove the cancer.
For more information:


AGITG clinical trials:  INTEGRATE II


Following the promising results from the INTEGRATE study, INTEGRATE II, an AGITG led Phase III clinical trial in gastro-oesophageal cancer opened to recruitment in Australia.  The first patient on the study was recruited late October 2016 at Townsville Hospital, QLD. Other active Australian sites include Gosford Hospital, NSW, Royal North Shore Hospital, NSW, Tweed Hospital, NSW, and Nambour Hospital, QLD.   Remaining ANZ sites will open throughout December 2016 and into January 2017, along with first Korean sites. Both Japanese and Taiwanese sites will open in 2017.

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 (docetaxel or irinotecan) 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 (or “refractory”) 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 (BAY 73-4506) 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 and GIST, regorafenib has been proven to be of benefit when other drugs have ceased to work. The AGITG Phase II trial — INTEGRATE, demonstrated efficacy with the use of regorafenib in AGOC, 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.

Cancer type:   Oesophago-gastric
Trial status:    Open to patient participation.
Eligibility: This trial is seeking patients with advanced gastro-oesophageal cancer (AGOC) that has returned after surgery, or where it is incurable (metastatic) at diagnosis.
For more information:


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