jenny shannon acticca-1 trial

February 2020: Trial Updates

Recent Sites Activated

The following sites have opened for AGITG trials in the past month:

DYNAMIC-Pancreas Royal Brisbane & Women’s Hospital

Tweed Hospital

DYNAMIC-III Central Coast Health District (Gosford & Wyong Hospitals)
DYNAMIC-Rectal Central Coast Health District (Gosford & Wyong Hospitals)
MASTERPLAN Chris O’Brien Lifehouse

Taking action on biliary tract cancer with ACTICCA-1 – A radiotherapy substudy

jenny shannon acticca-1 trial

The aim of ACTICCA-1 is to determine whether treating patients with a chemotherapy combination of cisplatin and gemcitabine following surgery for cancer of the biliary tract helps to reduce cancer recurrence.

Biliary tract cancer is uncommon, although incidence and mortality rates are increasing in most developed countries. In the study, eligible patients are randomly allocated to receive either chemotherapy with cisplatin and gemcitabine or capecitabine, to determine the most effective treatment.

Participation in the radiotherapy substudy will be offered to sites in the coming months. The substudy involves immediate second randomisation for R1 patients. Patients with R1 resection will be randomised to chemotherapy (capecitabine vs gem/cis), or chemotherapy followed by chemoradiation (capecitabine concurrent with radiation) for a period of five weeks. One hundred patients will be randomised internationally, and local recurrence rates analysed.

Researchers believe that the outcome of this substudy may establish a potential new role for radiation therapy in the treatment of patients for a subgroup of biliary tract cancer.

“It is recognised that there is a lack of high quality evidence regarding the role of adjuvant radiation therapy in biliary tract cancer,” says Dr Jenny Shannon, Principal Investigator of the trial.

“The addition of a radiation substudy to the ACTICCA-1 trial will optimise the clinical outcome measures from this multicentre international clinical trial, and help inform treatment decisions in this less common, but deadly disease.”

Currently, 22 patients have been enrolled in the study in Australasia, out of a target of 40, and 488 patients have been enrolled internationally. The study is open in 12 sites across New South Wales, Queensland, South Australia and Western Australia, as well as two sites in New Zealand.

Learn more about ACTICCA-1 here.

TOPGEAR: An International Effort

The purpose of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting in patients with resectable gastric cancer.

TOPGEAR is an international trial involving 66 sites in 15 countries across Australasia, Europe and Canada. It is an intergroup trial being conducted as a collaboration between the AGITG, TROG (Trans-Tasman Radiation Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer), and the CCTG (Canadian Cancer Trials Group).

“The trial is in the final stages of recruitment and with over 500 patients recruited, it is already the largest trial evaluating preoperative chemoradiation for gastric cancer,” says Prof Leong. “TOPGEAR continues to generate considerable interest at international meetings and the results are eagerly awaited by clinicians worldwide.”

International clinical trials are a vital method of conducting research into diseases that affect patients worldwide. This means that new therapies can be made available to patients around the world at the same time, and this trial has the potential to change practice on a global scale.

The interim results of TOPGEAR found that preoperative chemoradiation can be safely delivered to the vast majority of patients without a significant increase in treatment toxicity or surgical morbidity. As the study continues, the two treatment options will be compared statistically to see if preoperative chemoradiotherapy improves the rate of survival. Translational research is also being conducted to determine biomarkers that may affect patients’ progress.

In Australia and New Zealand, TOPGEAR has currently enrolled 231 patients. The study aims to enrol 570 participants worldwide.

Find out more about TOPGEAR here.

A step forward for ctDNA with DYNAMIC-Pancreas

DYNAMIC-Pancreas is one of three AGITG trials investigating ctDNA analysis, an emerging area in GI oncology that shows promise. DYNAMIC-III and DYNAMIC-Rectal studies are also open, investigating ctDNA-informed adjuvant therapy strategies in colon and rectal cancer respectively.

DYNAMIC-Pancreas aims to demonstrate that a ctDNA-informed adjuvant therapy approach following curative intent surgery for localised pancreatic cancer could reduce the proportion of patients that have detectable ctDNA after completing therapy, compared to the standard of care treatment.

Previous ctDNA studies have found that the percentage of patients with detectable levels of ctDNA in their blood correlated with the stage of cancer, and that the concentration of ctDNA in blood increased as the cancer stage increased[1]. The DYNAMIC studies will extend this knowledge by determining whether ctDNA can be used to inform decisions around therapy for patients by predicting the likelihood of relapse following surgery.

“I hope that ctDNA analysis will enable us to more accurately define recurrence risk and allow us to adjust treatment according to the individual patients’ risk of relapse,” says Dr Belinda Lee, Principal Investigator of the trial.

Pancreatic cancer has a high rate of relapse after surgery, which contributes to the low survival rate of this cancer. By understanding and grouping pancreatic cancer patients based on risk of recurrence and utilising a biomarker such as ctDNA, it may be possible to determine which patients are at greater risk of disease recurrence and escalate their chemotherapy to more intensive therapy accordingly.

DYNAMIC-Pancreas has recruited 15 patients out of a target of 438 at participating sites across Australia.

Find out more about DYNAMIC-Pancreas here.



MONARCC: An option for elderly patients with metastatic colorectal cancer

Metastatic colorectal cancer (mCRC) is a disease of the elderly, and anti-EGFR antibodies have not been well studied in this population. Therefore MONARCC aims to investigate the activity of panitumumab (monotherapy or combined with “light” chemotherapy, fluorouracil) in the first line setting, in molecularly selected patients over the age of 70 years.

Patients with RAS and BRAF wild-type mCRC can consent to participate in MONARCC providing they have not had prior treatment for their metastatic disease.

Dr Matthew Burge, Study Chair, believes that this regimen has the ability to be tolerated better thereby improving the patient’s quality of life and survival outcomes.

MONARCC is currently open at 19 sites in five states across Australia. As of 18 February, 16 patients have been enrolled in the study. MONARCC is one of the many AGITG trials that offer Australians living in rural, regional and remote areas an opportunity to patriciate in a clinical trial via alternative coordination models (e.g. teletrial or primary/satellite models). North Lakes Day Hospital is participating in MONARCC as satellite sites of Royal Brisbane and Women’s Hospital, with two patients currently being treated there. This initiative will enable access to a larger, eligible patient population and community access to this much needed study.

State Site
NSW Border Medical Oncology
Coffs Harbour Health Campus
Nepean Hospital
Northern Cancer Institute
Shoalhaven District Memorial Hospital
St Vincent’s Hospital Sydney
The Tweed Hospital
QLD Gold Coast University Hospital
North Lakes Day Hospital (satellite site of RBWH)
The Prince Charles Hospital
Princess Alexandra Hospital
Royal Brisbane and Women’s Hospital
Sunshine Coast University Hospital
SA Flinders Medical Centre
The Queen Elizabeth Hospital
Royal Hobart Hospital
VIC Austin Hospital
Monash Medical Centre
Sunshine Hospital


Find out more about MONARCC here.