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Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

NCT01677845 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-08-28

No results posted yet for this study

Summary

The aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program.

Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT). Dose escalation will be as follows:

There will be 3 cohorts consisting of 3 patients each.

Conditions

Interventions

RADIATION

Radiation

Dose Level 1: 54 Gy; 3 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions; Dose Level 2: 55.8 Gy; 3.1 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions; Dose Level 3: 57.6 Gy; 3.2 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions.

Sponsors & Collaborators

Principal Investigators

  • Nicholas J Sanfilippo, MD · NYU Langone Medical Center, Departement of Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-02-28
Completion
2017-08-25

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677845 on ClinicalTrials.gov