Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors
The purpose of this research study is to determine if radiation using proton beam therapy will kill the germ cell tumor in the participant's central nervous system. This type of radiation has been used previously on many patients with different types of cancers. There are two types of external radiation treatments, proton beam and photon beam. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can spare normal tissue more than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely increase the amount of radiation delivered to the tumor. We believe that proton beam therapy will potentially reduce side effects that participants would normally experience with photon radiation therapy.
Germ Cell Tumor
Central Nervous System Germ Cell Tumor
Radiation: Proton Beam radiation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects|
- To describe late complications of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation for this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To evaluate acute and subacute toxicities of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine 3 year progression free survival rate of patients with pure germ cell tumors and non-germinomatous germ cell tumors treated with proton radiation. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Proton beam radiation
Radiation therapy with proton beam
Radiation: Proton Beam radiation
Once a day, 5 days a week (Monday-Friday), for 4-8 weeks
- Before participants begin radiation therapy they will have scans done to prepare them for radiation treatment. Doctors will use the information gathered from these scans to plan the best way to deliver radiation to the tumor.
- Participants will receive treatment as an outpatient at the Francis H. Burr Proton Center located at the Massachusetts General Hospital.
- Not everyone who participates in this study will receive the same amount of proton radiation therapy. The length of time and amount of radiation that the participant will receive will depend on the type of germ cell tumor they have and the stage of the their disease.
- Radiation treatment will be given once a day, 5 days a week (Monday-Friday), for 4-8 weeks depending on the condition of the participant's disease.
- During each week of proton radiation therapy, participants will have a physical exam and be asked questions about their general health and any problems they might be experiencing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049230
|Contact: Shannon MacDonald, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Shannon MacDonald, M.D. 617-643-7250|
|Principal Investigator: Shannon MacDonald, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Karen Marcus, MD|
|Principal Investigator:||Shannon MacDonald, MD||Massachusetts General Hospital|