Phase II Study of High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull

Status: Active, not recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

There are two types of external radiation treatments; proton beam and photon beam radiation. What type of therapy participants will receive will depend upon the location of their tumor. Standard treatment would involve receiving either proton or photon radiation delivered by a three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a technique where the beams of radiation used in the treatment are shaped to match the tumor in order to avoid damaging the healthy surrounding tissue. Standard treatment also may include photon radiation delivered by intensity modulated (IMRT) technique. In this research study we are using an investigational technique to deliver proton radiation therapy called intensity modulated proton radiation treatment (IMPT) which is used to target cancer while sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during the treatment. This control over the intensity of the radiation dose has the potential to provide accuracy and allows us to more safely increase the amount of radiation delivered to the tumor. This accuracy may potentially reduce side effects that patients would normally experience with 3-D proton radiation therapy. Surgery is often an important component of the treatment for these tumors and may be integrated with the IMPT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pathological diagnosis of chondrosarcoma of the spine or sacrum or chordoma of the base of skull, spine or sacrum. Pathologic diagnosis to be confirmed at MGH or other participating institution.

• Participants need not have measurable disease. Lesion may be primary or recurrent after prior surgery. Patient tumor status: 1) Status post biopsy only and no further surgery planned, 2) Status post resection with gross residual disease, 3) Status post grossly complete research but with margins positive or close (10mm or less), 4) Status post biopsy and patient to have additional surgery and radiation

• No prior radiation treatment to the affected skull base, spine, or sacral region. Prior chemotherapy is allowed within 30 days of start of treatment

• 18 years of age or older

• ECOG Performance Status of 0, 1 or 2

• NOrmal organ and marrow function as outlined in the protocol

• No clinical, radiographic or other evidence of distant metastasis

• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Locations
United States
Massachusetts
Massachusetts General Hospital
Boston
Texas
MD Anderson Cancer Center
Houston
Time Frame
Start Date: December 2012
Estimated Completion Date: March 2032
Participants
Target number of participants: 64
Treatments
Experimental: IMPT
High dose IMPT
Authors
Thomas F. DeLaney, Paul D. Brown
Sponsors
Collaborators: M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials