Breast-Sparing Proton Therapy for Hodgkin's Disease

NCT02070393 | Terminated Early Phase 1 DMC

• 1 other identifier: IUHPTC-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hodgkins Disease

Keywords

Hodgkins Disease in Young Females; Breast Sparing Radiation Treatments

Outcome Measures

Primary Outcomes (1)

• Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.

  Dose-volume histogram data from both the delivered proton plan and the accompanying photon plan for target volumes and normal tissues, including: • Breast, heart, lung, thyroid, parotid glands , esophagus, spinal cord, \*liver, \*kidneys,

  12 months

Secondary Outcomes (1)

• Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.

  3 - 60 Months

Study Arms (1)

Radiation Treatment using Protons

EXPERIMENTAL

14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).

Radiation: Proton

Interventions

Proton RADIATION

14-24 Radiation treatments using Protons

Also known as: Breast sparing using proton beams

Radiation Treatment using Protons

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Proton Therapy Center

Bloomington, Indiana, 47408, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Protons

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Jeffery Buchsbuam, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: February 25, 2014
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)