Protocol title: An International Multi-centre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease.
International Sponsor: The Royal Marsden NHS Foundation Trust
Australian Sponsor: AGITG
Study Chair: Dr Amitesh Roy (Flinders Centre for Innovation in Cancer, Bedford Park SA)
Associate Oncology Program Manager: Cheryl Friend
Trial Coordinator: Jenna Mitchell
Contact Email: InterAACT@ctc.usyd.edu.au
Detailed information available on: Australian and New Zealand Clinical trials Registry
Trial Newsletter: None to date
GI Cancer Institute: $93,139 (2014)
This randomised phase II trial will evaluate activity and toxicity of two different chemotherapy regimens for the first line treatment of patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anus (SCCA). The main aim of the study is to set a standard of care for this relatively uncommon disease and inform feasibility and design of future multicentre, international phase III trials.
The exploratory translational substudy aims to provide important information on the biology of SCCA and identify tumour biomarker with a potential prognostic or predictive role.
Anal squamous cell cancer is a relatively uncommon cancer with approximately 150 cases in total being diagnosed in Australia every year. When anal cancer is localised in the anal canal, the standard treatment is a combination of chemotherapy and radiotherapy. However, in some patients cancer returns to the same area or spreads to other areas of the body. When cancer extends to a large area of the primary site or has spread beyond the primary site, chemotherapy is the treatment of choice. Unfortunately, due to the fact that anal cancer is a relatively rare disease there is currently no nationally and internationally agreed standard chemotherapy treatment in this situation. At present, the most frequently prescribed chemotherapy is a combination of two drugs called cisplatin and 5-fluorouracil (5-FU). However, a formal comparison of this combination with other chemotherapies such as carboplatin and paclitaxel (potentially more effective, or equally effective but potentially less toxic) has never been performed. There is an unmet need to compare regimens to help establish which combination regimen can be established as the most effective chemotherapy treatment and also can be used in future clinical trial in this tumour.
Study Design and Methods:
The InterAACT trial is an international multi-center anal cancer trial led by Dr Sheela Rao at Royal Marsden Hospital (RMH), London. The AGITG and NHMRC Clinical Trials Centre will work in collaboration with the RMH.
Eligible patients will be randomised to receive either cisplatin plus 5-FU, or carboplatin plus weekly paclitaxel. Randomisation will be carried out centrally using a computer programme at the Institute for Cancer Research (ICR). Patients will be randomised using the minimisation method taking into account the following factors:
- Region (Europe, North America & Australia),
- ECOG PS (0-1 versus 2),
- HIV positivity (yes vs. no) and
- extent of disease (locally recurrent vs. metastatic SCCA).
Approximately 50 international centres including 5 Australian centres are expected to participate in this trial. 80 participants will be recruited, of which 20 will come from Australia.
To view the study schema click here.