Proton Therapy in Reducing Toxicity in Anal Cancer

Jordan Kharofa

Status and phase: Active, not recruiting; Phase 2

Conditions: Anus Neoplasms

Treatments: Radiation: Proton therapy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03018418

UCCI-GI-16-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Proton Therapy and Chemotherapy

Experimental group

Description:

Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Treatment:

Drug: Chemotherapy

Radiation: Proton therapy