Proton Therapy in Reducing Toxicity in Anal Cancer

Phase 2

Active, not recruiting

• Conditions: Anus Neoplasms
• Interventions: Radiation: Proton therapy; Drug: Chemotherapy

• Registration Number: NCT03018418
• Lead Sponsor: Jordan Kharofa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-04
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Primary Completion: 2022-04-07
• Results First Submitted: 2023-05-11
• Results First Submitted QC: 2023-09-12
• Results First Posted: 2023-10-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-10
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Therapy and Chemotherapy	Proton therapy	Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Proton Therapy and Chemotherapy	Chemotherapy	Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Primary Outcome Measures

Name	Time	Method
Rates of Acute Toxicity	3 months	Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate	at 6 months from the completion of chemoradiation	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.
Rates of Late Toxicity	every 6 months up to 60 months	Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Overall Survival	every 6 months up to 24 months	This is an estimated percentage of participants that is alive at 2 years.
Distant Metastases Free Survival	every 6 months up to 60 months	This is the percentage of subjects that were free of distant metastases.
Quality of Life Changes	before treatment and 12 months after start of treatment	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.
Local Progression Free Survival	every 6 months up to 60 months	This is the percentage of subjects that were free of local progression.

Trial Locations

Locations (1)

UC Health; 🇺🇸 Cincinnati, Ohio, United States