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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:December 2012
End Date:March 2032

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

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.

- 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Participants may not be receiving any other investigational agents

- Participants with metastases

- Evidence of brainstem/cord/cauda or other neuromuscular or neurosensory malfunction
from causes other than effects of local tumor growth or metabolic effects of tumor

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements. Disease/conditions characterized by high radiation sensitivity.
These include genetic diseases, such as ataxia telangiectasia

- Pregnant women

- Individuals with a history of a different malignancy are ineligible except for the
following circumstance. Individuals with a history of other malignancies are eligible
if they have been disease-free for at least 5 years and are deemed by the investigator
to be at low risk for recurrence of that malignancy. Individuals with the following
cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer
in situ, and basal cell or squamous cell carcinoma of the skin.Individuals treated for
localized, node-negative cancers > 2 years ago with no evidence of cancer are also
considered eligible.

- HIV-positive individuals on combination antiretroviral therapy
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Thomas F. DeLaney, M.D.
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mi
from
Boston, MA
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Houston, Texas 77030
Principal Investigator: Paul D. Brown, M.D.
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mi
from
Houston, TX
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