Breast-Sparing Proton Therapy for Hodgkin's Disease (Breast Sparing)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02070393|
Recruitment Status : Terminated (Closure of Indiana University Health Proton Center in December 2014)
First Posted : February 25, 2014
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hodgkins Disease||Radiation: Proton||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Radiation Treatment using Protons
14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).
14-24 Radiation treatments using Protons
Other Name: Breast sparing using proton beams
- Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues. [ Time Frame: 12 months ]
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,
- Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma. [ Time Frame: 3 - 60 Months ]
- Acute toxicity as per CTCAE v4.0
- Local, regional, and distal control of the disease at 3 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070393
|United States, Indiana|
|Indiana University Health Proton Therapy Center|
|Bloomington, Indiana, United States, 47408|
|Principal Investigator:||Jeffery Buchsbuam, MD||Indiana University|