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
Carcinoma of Anal Canal
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy [ Time Frame: 2-year locoregional control in patients, which is defined as the absence of locoregional recurrence 2 years after treatment start. ] [ Designated as safety issue: No ]
- Complete response (CR) rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]Tumor assessment will be done by the investigator according to the RECIST 1.1. criteria.
- Colostomy-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]2-year colostomy-free survival (patients without colostomy two-years after treatment start).
- Functional colostomy-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]2-year functional colostomy-free survival (patients without colostomy and without stool incontinence or other sphincter symptoms interfering with activities of daily life two years after treatment start, which correspond to grade 3 toxicity according to common toxicity criteria National Cancer Institute-Common Toxicity Criteria for Adverse Event (NCI-CTCAE) version 4.0.
- Overall survival (OS) [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]2-year overall survival (proportion of patients alive two years after treatment start) and median overall survival (median of the interval (days) between treatment start and death for any cause).
- Progression-free survival (PFS) [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]2-year PFS (proportion of patients progression-free two years after treatment start) and median PFS according to the RECIST 1.1 criteria. PFS is defined as the interval (days) between registration and the date of progression (based on the actual tumor assessment date), or death for any cause, whichever comes first. The death of a patient without a reported progression will be considered as an event on the date of death. Patients who have neither progressed nor died will be censored on the date of last evaluable tumor assessment. Patients who had no post-baseline assessments and did not have an event will be censored at the time of registration.
- Tolerability and safety profile of this regimen. [ Time Frame: Early (6 weeks after treatment) and late (up to 2 and 5 years after treatment). ] [ Designated as safety issue: Yes ]Toxicities will be assessed according to the NCI-CTCAE (version 4.0).
- Role of PET for staging and outcome prediction. [ Time Frame: 5 years ] [ Designated as safety issue: No ]Predictive value of PET for PFS. Comparison of PET for determination of complete response with radiologic response and clinical response.
|Study Start Date:||December 2012|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine, mitomycin, panitumumab and radiotherapy
RADIOTHERAPY: daily fraction dose of 1.8Gy , 5 days a week between day 1 and 45 Intensity modulated radiotherapy (IMRT), using a linac based facility or helical tomotherapy, is obligatory.
The first treatment sequence consists of a total dose of 36 Gy in 20 daily fractions of 1.8 Gy on five days a week.
The second treatment sequence consists of a total dose of 23.4 Gy in 13 daily fractions of 1.8 Gy on five days a week.
PANITUMUMAB: 6 mg/kg IV over 60 min infusion on days 1, 15 and 29
MITOMYCIN: 10 mg/m2 IV over 15 min infusion on days 1 and 29
CAPECITABINE: 825 mg/m2 oral twice daily on days 1 to 45
External beam radiotherapy (daily fraction dose 1.8Gy) on Monday through Friday starting on study day 1.
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.
-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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843452
|Bern, Switzerland, 3010|
|Hôpitaux Universitaires de Genève (HUG)|
|Centre Hospitalier Universitaire Vaudois|
|Hôpital du Valais (RSV)|
|Principal Investigator:||Oscar Matzinger, MD||Centre Hospitalier Universitaire Vaudois|