- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346124
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
September 1, 2020 updated by: Tom DeLaney, MD, Massachusetts General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
- 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
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Massachusetts General Hospital
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IMPT
High dose IMPT
|
Radiation given once a day Monday-Friday
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Tumor Control
Time Frame: 3 years
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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.
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sites of Failure
Time Frame: 3 years
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To determine the anatomic sites of failure.
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3 years
|
Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE
Time Frame: 3 years
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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
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3 years
|
Functional Status
Time Frame: 3 years
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To assess the late functional status of the cranial/lumbar/sacral nerves, brain stem, and spinal cord after treatment.
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ANTICIPATED)
March 20, 2022
Study Completion (ANTICIPATED)
March 1, 2032
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
April 29, 2011
First Posted (ESTIMATE)
May 2, 2011
Study Record Updates
Last Update Posted (ACTUAL)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-133
- 2P01CA021239 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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