Expired Study
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Bloomington, Indiana 47408


Purpose:

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


Study summary:

According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there will be an estimated 8,490 new cases of Hodgkin's Lymphoma (HL) in the United States in 2010, with an estimated 1,320 deaths (Jemal, Siegel et al.). The unadjusted rates of 5 year overall survival are approximately 95%, and remain among the highest of all childhood and adult malignancies. With many children and young adults surviving into advanced age, the impetus has been to develop less toxic yet equally effective treatments. One of the main approaches taken over the last 25 years to minimize long-term treatment toxicity has been to limit the amount and volume of radiation received by patients. This pilot study continues along those lines, attempting to further refine the delivery of radiation therapy (RT) in order to avoid one of the most notorious long-term side-effects: secondary breast cancer. Multiple studies investigating late toxicity in long-term survivors of pediatric Hodgkin's Lymphoma have shown the risk of breast cancer in young females receiving mediastinal radiation to be 50 times greater than their age-matched counterparts. The Late Effects Study Group, with a median follow-up of 17 years, reported a breast cancer incidence of 16% with a standardized incidence ratio of 55.5 (Bhatia, Yasui et al. 2003). Through utilization of breast-sparing proton therapy, we hope to provide young female patients with the benefits of radiation therapy while decreasing their risk of secondary breast cancer, thus increasing the therapeutic ratio. In a prior computer-based, in-silico, dose planning study, utilizing the most basic beam orientation (a single PA beam), we showed that dose to breast tissue was reduced by a minimum of at least 80% with proton treatment compared to standard AP-PA photon treatment (in publication). Furthermore, dose to clinical target volume was maintained, and dose to other normal structures was statistically no worse. We now aim to validate these findings by verifying the beam range, in-vivo, via post-treatment combined Positron Emission Tomography-Computer Tomography (PET-CT) imaging in young females undergoing supra-diaphragmatic radiotherapy for Hodgkin's Disease.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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


Study is Available At:


Original ID:

IUHPTC-01


NCT ID:

NCT02070393


Secondary ID:


Study Acronym:

Breast Sparing


Brief Title:

Breast-Sparing Proton Therapy for Hodgkin's Disease


Official Title:

Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study


Overall Status:

Terminated


Study Phase:

Phase 0


Genders:

Female


Minimum Age:

10 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Closure of Indiana University Health Proton


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffery Buchsbuam, MD
Principal Investigator
Indiana University

Study Dates

Start Date:September 2011
Completion Date:February 2015
Completion Type:Actual
Primary Completion Date:February 2015
Primary Completion Type:Actual
Verification Date:February 2015
Last Changed Date:February 3, 2015
First Received Date:April 19, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
Time Frame:3 - 60 Months
Safety Issues:True
Description:Acute toxicity as per CTCAE v4.0 Local, regional, and distal control of the disease at 3 years
Outcome Type:Primary Outcome
Measure:Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
Time Frame:12 months
Safety Issues:True
Description: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,

Study Interventions

Intervention Type:Radiation
Name:Proton
Description:14-24 Radiation treatments using Protons
Arm Name:Radiation Treatment using Protons
Other Name:Breast sparing using proton beams

Study Arms

Study Arm Type:Experimental
Arm Name:Radiation Treatment using Protons
Description:14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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