Back to resultsProton Therapy in Reducing Toxicity in Anal Cancer
Primary Purpose
Anus Neoplasms
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proton therapy
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Anus Neoplasms focused on measuring Anal Cancer
Eligibility Criteria
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.
Sites / Locations
- UC Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton Therapy and Chemotherapy
Arm Description
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Outcomes
Primary Outcome Measures
Rates of Acute Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Secondary Outcome Measures
Rates of Late Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
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.
Local Progression Free Survival
This is the percentage of subjects that were free of local progression.
Overall Survival
This is an estimated percentage of participants that is alive at 2 years.
Distant Metastases Free Survival
This is the percentage of subjects that were free of distant metastases.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03018418
Brief Title
Proton Therapy in Reducing Toxicity in Anal Cancer
Official Title
A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jordan Kharofa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anus Neoplasms
Keywords
Anal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton Therapy and Chemotherapy
Arm Type
Experimental
Arm Description
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Proton therapy
Intervention Description
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
5FU, Mitomycin
Intervention Description
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Primary Outcome Measure Information:
Title
Rates of Acute Toxicity
Description
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rates of Late Toxicity
Description
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Time Frame
every 6 months up to 60 months
Title
Complete Response Rate
Description
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
Title
Local Progression Free Survival
Description
This is the percentage of subjects that were free of local progression.
Time Frame
every 6 months up to 60 months
Title
Overall Survival
Description
This is an estimated percentage of participants that is alive at 2 years.
Time Frame
every 6 months up to 24 months
Title
Distant Metastases Free Survival
Description
This is the percentage of subjects that were free of distant metastases.
Time Frame
every 6 months up to 60 months
Title
Quality of Life Changes
Description
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.
Time Frame
before treatment and 12 months after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Kharofa, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proton Therapy in Reducing Toxicity in Anal Cancer
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