High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
|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: NCT01346124|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chordoma of Spine Chordoma of Sacrum Chordoma of Base of Skull Chondrosarcoma of the Spine Chondrosarcoma of the Sacrum||Radiation: High Dose Intensity Modulated Proton Radiation||Not Applicable|
- Before beginning radiation therapy, the participants will have a radiation planning computed tomographic (CT) scan of the tumor site. This is considered standard of care and the doctor will use the images from this scan to plan the radiation treatment.
- Participants may also receive surgery either before or after the study radiation treatment. This surgery is also considered standard of care and would be done regardless of being in the research study.
- The IMPT technique for delivering radiation is for research purposes only. Radiation treatment to the affected tumor will be given daily, Monday through Friday.
- The following procedures will be performed once a week during treatment: assessment of nerve, neuromuscular, motor and sensory function by clinical exam and toxicity assessment.
- Participants will return for follow-up visits after completion of the radiation treatment at the following intervals: 6 weeks after completion of treatment, 6 months after treatment, every 6 months thereafter for 4 years, and then each year after for up to 15 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||March 20, 2022|
|Estimated Study Completion Date :||March 2032|
High dose IMPT
Radiation: High Dose Intensity Modulated Proton Radiation
Radiation given once a day Monday-Friday
Other Name: IMPT
- Local Tumor Control [ Time Frame: 3 years ]To define the efficacy or high dose fractionated radiation alone or combined with surgery in achieving local tumor control in patients with base of skull chordomas and patients with spine/sacral chordomas or chondrosarcomas using intensity modulated photon and proton techniques.
- Sites of Failure [ Time Frame: 3 years ]To determine the anatomic sites of failure.
- Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE [ Time Frame: 3 years ]To evaluate the acute and late normal tissue tolerance of high dose intensity modulated proton/photon radiation treatment in this patient population, as assessed according to the CTCAE
- Functional Status [ Time Frame: 3 years ]To assess the late functional status of the cranial/lumbar/sacral nerves, brain stem, and spinal cord after treatment.
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): NCT01346124
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|