Clinical trial

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

Name

UCCI-GI-16-01

Description

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.

Trial arms

Trial start

2017-01-04

Estimated PCD

2022-04-07

Trial end

2024-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Proton therapy

Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions

Arms:

Proton Therapy and Chemotherapy

Chemotherapy

5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29

Arms:

Proton Therapy and Chemotherapy

Other names:

5FU, Mitomycin

Size

Primary endpoint

Rates of Acute Toxicity

3 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2024-05-10

1 organization

1 drug

1 indication

Organization

Jordan Kharofa

Drug

Docetaxel

Indication

Anus Neoplasms