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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

Phase 2
18 Years
Open (Enrolling)
Chordoma of Spine, Chordoma of Sacrum, Chordoma of Base of Skull, Chondrosarcoma of the Spine, Chondrosarcoma of the Sacrum

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Trial Information

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

- 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

- 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.

- HIV-positive individuals on combination antiretroviral therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Tumor Control

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Thomas F. DeLaney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Chordoma of Spine
  • Chordoma of Sacrum
  • Chordoma of Base of Skull
  • Chondrosarcoma of the Spine
  • Chondrosarcoma of the Sacrum
  • radiation
  • IMRT
  • IMPT
  • Chondrosarcoma
  • Chordoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Massachusetts General Hospital Boston, Massachusetts  02114-2617