Evaluation of Proton Therapy in Pediatric Cancer Patients
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03223766|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 7, 2018
|Condition or disease|
For the clinical trial being described in this registration, participants will be observed to collect data for baseline assessment of disease and patient characteristics. This will be done before proton therapy on other trials followed by serial standard-of-care clinical assessments to evaluate acute and late complications, disease control, treatment-related mortality, and overall survival.
- To estimate the incidence of radiation associated grade 3 and grade 4 non-hematologic toxicities at 1, 3, 5, and 10 years in a radiated region specific manner after the initiation of proton therapy.
- To estimate the incidence of necrosis, vasculopathy, and symptomatic and permanent neurologic deficits at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for central nervous system (CNS) tumors in an irradiated region directed manner.
- To estimate the incidence of treatment-related mortality at 5 and 10 years after the initiation of proton therapy.
- To estimate the incidence of subsequent malignancies at 5 and 10 years after the initiation of proton therapy in an irradiated region directed manner.
- To estimate the incidence of fracture and osteonecrosis at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for musculoskeletal tumors in an irradiated region directed manner.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Phase IV Clinical Trial of Proton Therapy in Pediatric Cancer|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||July 2037|
|Estimated Study Completion Date :||July 2037|
Participants will be those enrolled to receive proton therapy on other protocols at SJCRH on or after November 18, 2015.
- Incidence of radiation-associated non-hematologic toxicities [ Time Frame: From baseline through 10 years ]All Grade 3 and Grade 4 non-hematologic toxicities will be reviewed to determine attribution to proton therapy given in other clinical trials at SJCRH and the number reported.
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): NCT03223766
|Contact: John T. Lucas, Jr., MS, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: John T. Lucas, Jr., MS, MD 866-278-5833 email@example.com|
|Principal Investigator: John T. Lucas, Jr., MS, MD|
|Principal Investigator:||John T. Lucas, Jr., MS, MD||St. Jude Children's Research Hospital|