Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT01049230|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Tumor Central Nervous System Germ Cell Tumor||Radiation: Proton Beam radiation||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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
- 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 ]
- 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 ]
- 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 ]
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): NCT01049230
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Shannon MacDonald, MD||Massachusetts General Hospital|