Carcinoma of Anal Canal Clinical Trial
Official title:
Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal
There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment components used in this study have been selected on scientific rationale. The trial regimen should be feasible with acceptable toxicity and outcome similar to historic series.
OBJECTIVES:
Primary:
-To assess efficacy of treatment regimen composed of capecitabine, mitomycin, panitumumab,
and radiotherapy in terms of locoregional control rate in patients with stage II-IIIB
squamous-cell carcinoma of the anal canal.
Secondary:
- To further assess efficacy of this regimen based on complete response (CR) rate,
colostomy-free survival, functional colostomy-free survival, overall survival (OS), and
progression-free survival (PFS).
- To assess the tolerability and safety profile of this regimen.
- To assess the role of PET for staging and outcome prediction (for those patients who
had PET following local standards).
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment