Chordoma of SpineNCT01346124
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
A study testing High Dose Intensity Modulated Proton Radiation in people with Chordoma of Spine and Chordoma of Sacrum, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma of Spine, Chordoma of Sacrum, Chordoma of Base of Skull
- What is being tested?
- High Dose Intensity Modulated Proton Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read the 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.
- Conditions
- Chordoma of Spine, Chordoma of Sacrum, Chordoma of Base of Skull, Chondrosarcoma of the Spine, Chondrosarcoma of the Sacrum
- Being tested
- High Dose Intensity Modulated Proton Radiation
- Keywords
- radiation, IMRT, IMPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Intensity Modulated Proton RadiationRadiation
Also called IMPT
Radiation given once a day Monday-Friday
| Study group | Role | What they receive |
|---|---|---|
| IMPT | Experimental | High dose IMPT Receives: Radiation: High Dose Intensity Modulated Proton Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control
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.
Measured: 3 years
Secondary outcomes (3)
Sites of Failure
To determine the anatomic sites of failure.
Measured: 3 years
Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE
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
Measured: 3 years
Functional Status
To assess the late functional status of the cranial/lumbar/sacral nerves, brain stem, and spinal cord after treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startDec 2012
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chordoma of SpineStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kevin X. Liu, MD, DPHIL, Massachusetts General Hospital
- Investigators
- Thomas F. DeLaney, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346124
- Sponsor's protocol ID
- 10-133
- Other IDs
- 2P01CA021239
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2011
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01346124
- Acronym / sponsor ID
- 10-133
- Conditions
- Chordoma of Spine, Chordoma of Sacrum, Chordoma of Base of Skull, Chondrosarcoma of the Spine, Chondrosarcoma of the Sacrum
- Keywords
- radiation, IMRT, IMPT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMPT | Experimental | Radiation: High Dose Intensity Modulated Proton RadiationHigh dose IMPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Intensity Modulated Proton RadiationAlso: IMPTRadiation given once a day Monday-Friday | Radiation | IMPT |
Primary outcome
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.
3 secondary outcomes
Sites of Failure
Time frame: 3 years
Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE
Time frame: 3 years
Functional Status
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Related trials for Chordoma of Spine
RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F. DeLaney, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Intensity Modulated Proton Radiation in people with Chordoma of Spine and Chordoma of Sacrum, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.