InterAACT A Multicentre Randomised Phase II Advanced Anal Cancer Trial
Research type
Research Study
Full title
An International Multicentre 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
IRAS ID
130983
Contact name
Sheela Rao
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2013-001949-13
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is an international, multicentre, open label, randomised phase II trial comparing two chemotherapy regimens for the first line treatment of patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anus.
Systemic chemotherapy remains the mainstay of treatment for patients with advanced squamous cell carcinoma of the anus. However, at present there is no consensus on the standard chemotherapy treatment. This study will provide evidence for the optimal first line treatment option, thus setting the standard of care for this disease. It will also establish the optimal chemotherapy backbone to use in combination with new targeted agents in future trials.
Patients will be eligible if they have a diagnosis of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus, ECOG PS ≤2 and measurable disease according to RECIST criteria v1.1. Patients will be randomised in a 1:1 ratio to receive 24 weeks of treatment with cisplatin plus 5-FU or carboplatin plus weekly paclitaxel. Tumour assessment will be performed every 12 weeks.
The primary endpoint of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival, toxicity and quality of life. The study also includes an explorative biomarker analysis with the collection of archived tumour tissue and blood samples at baseline and upon progression.
Using the selection trial design procedure for phase II randomised trials, this trial will require 40 patients to be recruited to each arm.This study has been approved by the International Rare Cancers Initiative (IRCI) and has been designed as a multicentre, international trial. Approximately 50 international centres are estimated to participate in this trial and the recruitment is anticipated to be completed within 3 years.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/1463
Date of REC Opinion
16 Oct 2013
REC opinion
Favourable Opinion