NCT01843452

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Carcinoma of Anal Canal

Interventions

Type	Name	Description
RADIATION	RADIOTHERAPY	External beam radiotherapy (daily fraction dose 1.8Gy) on Monday through Friday starting on study day 1. * Days 1-28, dose of 36 Gy in 1.8 Gy/fraction (20 fractions) to the clinical target volume 1 (CTV1) including the primary tumor and involved lymph nodes and areas at risk for metastatic spread (which includes gross tumour volumes (GTV) and a 1-cm expansion, mesorectal space, inguinal, femoral, external iliac, internal iliac, and common iliac vessels). * Days 29-45, a boost dose of 23.4 Gy in 1.8 Gy/fraction (13 fractions) to the GTV.
BIOLOGICAL	PANITUMUMAB	6 mg/kg IV administered over 60 min infusion on days 1,15 and 29.
DRUG	MITOMYCIN	10 mg/m2 IV administered over 15 min infusion on days 1 and 29.
DRUG	CAPECITABINE	825mg/m2 orally twice daily on study days 1 through 45.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-04-30
• Last updated: 2016-05-19

Locations

4 sites across 1 country: Switzerland