Hodgkins Disease Clinical Trial
Official title:
Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study
The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00764829 -
Blood Samples to Evaluate Biomarkers of Donor Chimerism
|
N/A | |
Terminated |
NCT01500161 -
Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
|
Phase 2 | |
Completed |
NCT00901225 -
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT02639559 -
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00697684 -
Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by Allogeneic Stem Cell Transplant
|
Phase 1 | |
Completed |
NCT00802113 -
Autologous and Allogeneic Transplant for Relapsed Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT01951885 -
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
|
Phase 3 | |
Completed |
NCT00754286 -
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
|
N/A | |
Completed |
NCT00364676 -
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
|
Phase 1 | |
Completed |
NCT00571662 -
Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT00713882 -
Health and Psychosocial Outcomes in Long-Term Lymphoma Survivors
|
N/A |