Proton Therapy in Reducing Toxicity in Anal Cancer

Anus Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03018418
• Other study ID #: UCCI-GI-16-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 4, 2017
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: July 2024
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anus Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	UC Health	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Kharofa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Acute Toxicity	Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity	3 months
Secondary	Rates of Late Toxicity	Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity	every 6 months up to 60 months
Secondary	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
Secondary	Local Progression Free Survival	This is the percentage of subjects that were free of local progression.	every 6 months up to 60 months
Secondary	Overall Survival	This is an estimated percentage of participants that is alive at 2 years.	every 6 months up to 24 months
Secondary	Distant Metastases Free Survival	This is the percentage of subjects that were free of distant metastases.	every 6 months up to 60 months
Secondary	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