High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
|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: NCT00592345|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mesenchymal Tumor||Radiation: Proton Beam Radiation Radiation: Photon Beam Radiation Radiation: Interoperative radiation||Phase 1 Phase 2|
- In this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor.
- Radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. As part of the treatment planning process, participants will need two treatment planning CT scans and 2-3 treatment planning sessions.
- Participants will receive, in total, 39-43 photon/proton treatments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2016|
Radiation: Proton Beam Radiation
- To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. [ Time Frame: 3 years ]
- To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment. [ 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): NCT00592345
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|