AGITG clinical trials:  InterAACT

InterAACT is an international multi-centre, open-label, randomised phase II trial. It compares cisplatin plus 5-fluorouracil to carboplatin plus weekly paclitaxel in these patients with anal cancer that is not amenable to surgery — either recurrent disease locally or metastatic disease.

Anal cancer is relatively rare with approximately 150 cases diagnosed in Australia each year. For people whose cancer relapses and/or spreads after initial treatment, unfortunately the outlook is generally quite poor, with no agreed standard chemotherapy treatments. Therefore, InterAACT aims to address the best treatment option for this group of patients.

Additionally, the InterAACT trial is part of the International Rare Cancer Initiative (IRCI), a worldwide collaboration to help develop international clinical trials for patients with rare cancers as a means of increasing the efficient acquisition of data to answer questions in rare tumour types.

Cancer type:   Anal
Trial status:    Open to patient participation
Eligibility:   The trial is seeking patients with inoperable locally recurrent or metastatic anal cancer.
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AGITG clinical trials:  A La CaRT

A La CaRT is the Australasian Laparoscopic Cancer of the Rectum Trial:   a phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer. It seeks to determine whether the less invasive laparoscopic-assisted surgery is equal to open rectal resection in safety and effectiveness.

Rectal cancer is a major public health concern, particularly in Australia and New Zealand where the incidence is amongst the highest in the world.

Surgical resection is an important component of the treatment for rectal cancer with the growing use of laparoscopic surgery in Australia over recent years. However, reliable evidence of its safety, efficacy and long-term effectiveness when compared with open surgery for cancer related outcomes is not available. While potential advantages of laparoscopic surgery include less time in hospital, smaller scars and less post-operative morbidity,  these advantages have not been validated in a randomised trial.

Therefore, before laparoscopic procedures can become recommended as standard, it is essential to determine reliably whether this approach is at least equivalent to open surgery in terms of pathological results, patient-rated and long-term clinical outcomes. This trial is also assessing morbidity, mortality associated with surgery, disease-free survival, disease recurrence, quality of life and cost-effectiveness.

Cancer type:   Rectal
Trial status:  In follow-up
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AGITG clinical trials:  PETACC 6

PETACC-6 aims to assess whether the addition of oxaliplatin to capecitabine at the time of radiation therapy preoperatively, followed by post-operative chemotherapy with the same combination rather than capecitabine alone in both instances, reduces the risk of recurrence or death in patients with locally advanced rectal cancer.

Five-year overall survival rate remains below 70% for locally advanced disease. Even with improved rates of local control, no improvements have been seen in distant disease recurrence, or overall survival. This trial hopes to establish whether a combination chemotherapy regimen with the addition of oxaliplatin, will reduce recurrence of disease as it has been proven to do so in stage III colon cancer.

Capecitabine was chosen as a substitute for intravenous 5-FU for all treatment arms of the study as studies have shown equivalence of 5-FU and capecitabine with regards to response rates and disease free survival rates for stage III bowel cancer; with capecitabine offering convenience and a varied toxicity profile. The combination strategy has proved efficacious and safe in phase II trials of chemo-radiotherapy before surgery, and in large phase III trials for stage II/III colon cancer.

Cancer type:   Rectal
Trial status:  In follow-up
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