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Intervention protocol 13

Radiotherapy of squamous cell carcinoma of the anus

Objectives Radiotherapy with or without chemotherapy is the primary treatment for cancers of the anus. The aim of the current protocol is to integrate and compare the value of MRI, CT, FDG-PET scan and PET for staging, target definition, detection of hypoxia, and response to treatment in patients with anal carcinoma treated with radical chemoradiation or radiotherapy alone. Anal cancer seems to be associated with HPV infection, although the know¬ledge about the connection between HPV and anal cancer is more limited than in the case of cervical cancer. Assessment of HPV regulated proteins as well as other possible prognostic factors in tumour tissue will be initiated by measurement of HPV-DNA in a separable protocol. The role of tumour hypoxia for the outcome of anal cancer radiotherapy is unclear.
Study outline (intervention) An ongoing image protocol (IMANAL), approved by the ethical committee, investigates MR, CT and FDG-PET in staging, planning and response evaluation. This protocol will be amended with the use of hypoxia markers, DCE-MRI and HPV analysis. Fifty patients will be included in the amended protocol, start early 2009, inclusion period 3 years. Endpoints: Explore if the use of hypoxia markers and DCE-MR can predict resistance to therapy. Hypoxia markers: FAZA, F-MISO or Cu 64-ATSM or other possible markers. Value of HPV-DNA as prognostic factor.
Expected impact The ultimate goal of the project is to improve patient outcome. The project will lead to improved staging, target definition, sparing of normal tissues and more precise dose delivery. The role of hypoxia and HPV infection as potential prognostic factors in anal cancer will be clarified.
Linkages with work packages WP 1, 2, 3, 4, 6, 7, 8, 9.