Phase 2 Trial to Assess the Efficacy and Safety of Chemoradiation With 5-fluorouracil, Mytomicin C and Panitumumab as a Treatment for Anal Squamous Cell Carcinoma (VITAL)

NCT01285778 Phase 2 COMPLETED

Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association: * 5-FU 1000mg/m2 on days 1-4 and 29-32 * Mitomycin C 10mg/m2 on days 1 and 29 * Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks

Details

Lead sponsor	Grupo Espanol Multidisciplinario del Cancer Digestivo
Phase	Phase 2
Status	COMPLETED
Enrolment	58
Start date	2010-10
Completion	2017-03-24

Conditions

• Anal Squamous Cell Carcinoma

Interventions

• panitumumab, mytomicin C, 5-FU, radiation

Primary outcomes

• Three-year disease-free survival rate — 3 years
  To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and Panitumumab concurrently with radiation therapy as treatment for anal squamous cell carcinoma

Countries

Spain