Proton Therapy in Reducing Toxicity in Anal Cancer

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

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 Overview

• Status: Active, not recruiting
• Conditions: Anus Neoplasms
• Intervention / Treatment: Radiation: Proton therapy; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45044
      • UC Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jordan Kharofa
• Investigators: Principal Investigator: Jordan Kharofa, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): April 7, 2022
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimated): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: UCCI-GI-16-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO