Breast-Sparing Proton Therapy for Hodgkin's Disease

Stopped early · Early Phase 1

Conditions studied: Hodgkins Disease

In brief

The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.

Key facts

Study ID: NCT02070393
Run by: Indiana University
People needed: 3
Starts: 2011-09-01
Expected to finish: 2015-02-01
Last updated by the study team: 2015-02-04

Who can join

Age: 10 and older, up to 30. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female sex
Age >/= 10 years old and < 30 years old
Pathologically confirmed classical Hodgkin's Lymphoma
At least one site of disease located above the diaphragm
Signed study-specific consent prior to initiation of therapy
Women of child-bearing potential must have a negative pregnancy blood test within 7 days of starting protocol therapy.

You may not qualify if…

Previous radiation therapy to any part of the body.
Parenchymal lung involvement at initial presentation or any patient that may need whole lung irradiation as per institutional guidelines.
Lymphocyte predominant histology not eligible.
Significant infection or other coexistent medical condition that would preclude protocol therapy such as:
History of HIV/AIDS
History of collagen Vascular Disease
Symptomatic congestive heart failure
Unstable angina pectoris or myocardial infarction within 6 months
Uncontrolled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg on 2 consecutive measurements separated by 1 week).
History of uncontrolled diabetes
Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements

Where it is running

Indiana University Health Proton Therapy Center — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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