Proton Therapy in Reducing Toxicity in Anal Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.

Official Title
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A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer

Conditions
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Anus Neoplasms

Intervention / Treatment
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* Radiation: Proton therapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Karnofsky Performance Status >70% Histologically documented squamous or basaloid carcinoma of the anal canal Stage T2-4 disease with any N category Exclusion Criteria: • Patients with a life expectancy of < 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Therapy and Chemotherapy<br>Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy | Radiation: Proton therapy<br>* Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions<br>Drug: Chemotherapy<br>* 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29<br>* Other names: Mitomycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Acute Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Late Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | every 6 months up to 60 months | 
| Complete Response Rate | Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence. | at 6 months from the completion of chemoradiation | 
| Local Progression Free Survival | This is the percentage of subjects that were free of local progression. | every 6 months up to 60 months | 
| Overall Survival | This is an estimated percentage of participants that is alive at 2 years. | every 6 months up to 24 months | 
| Distant Metastases Free Survival | This is the percentage of subjects that were free of distant metastases. | every 6 months up to 60 months | 
| Quality of Life Changes | Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points. | before treatment and 12 months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal Cancer