Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
Squamous Cell Carcinoma of Anal Canal
Radiation: Intensity Modulated Radiation Therapy (IMRT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal|
- Toxicity [ Time Frame: 1 month post end of treatment ] [ Designated as safety issue: Yes ]Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
- Local tumor response rate [ Time Frame: 8 weeks post end of radiation treatment ] [ Designated as safety issue: Yes ]Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
- Overall cancer-free survival [ Time Frame: 5 years post end of treatment ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 5 years post end of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2022|
|Estimated Primary Completion Date:||September 2021 (Final data collection date for primary outcome measure)|
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
200mg Nimotuzumab once a week for 12 weeksRadiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382745
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Te Vuong, MD||Jewish General Hospital|