Proton Therapy in Reducing Toxicity in Anal Cancer

Jordan Kharofa14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anus Neoplasms

Interventions

Proton therapyRADIATION

Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions

ChemotherapyDRUG

5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC Health

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Rates of Acute Toxicity

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Time frame: 3 months

Secondary Outcomes

Rates of Late Toxicity

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Time frame: 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.

Time frame: at 6 months from the completion of chemoradiation

Local Progression Free Survival

This is the percentage of subjects that were free of local progression.

Time frame: every 6 months up to 60 months

Overall Survival

This is an estimated percentage of participants that is alive at 2 years.

Time frame: every 6 months up to 24 months

Distant Metastases Free Survival

This is the percentage of subjects that were free of distant metastases.

Time frame: 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.

Data from ClinicalTrials.gov

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