ChordomasNCT01449149

Proton Radiation for Chordomas and Chondrosarcomas

A study testing Proton Therapy in people with Chordomas and Chondrosarcomas, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chordomas, Chondrosarcomas
What is being tested?: Proton Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2010to 4 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically confirmed diagnosis of chordoma or chondrosarcoma.
Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
Patients must have an ECOG score equal to or less than 2.
Age ≥ 18 years.
Patients must be able to provide informed consent.
Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented.
Tumors arising in the skull and spine.

Who cannot join

Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
Pregnant women.
Actively being treated on any other therapeutic research study.
Tumors arising outside of the CNS.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Proton Radiation For Chordomas and Chondrosarcomas

Read the detailed description

This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Conditions: Chordomas, Chondrosarcomas
Being tested: Proton Therapy
Keywords: Age 18 or greater, No prior radiation
Medical subject headings: Chordoma, Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton TherapyRadiation

Study groups in NCT01449149
Study group	Role	What they receive
Proton group	Experimental	Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions Receives: Radiation: Proton Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Proton RT for Chordomas and Chondrosarcomas
The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine.
The feasibility, as defined by ≥10% of patients experiencing either: unsatisfactory dosimetry, inability to complete all of his/her treatments within 10 days of estimated completion date and requiring no break >5 days, and no greater than 20% of patients experiencing ≥grade 3 toxicity from RT.
Measured: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months

Secondary outcomes (2)

Acute Toxicities
Any grade 3 or higher toxicity observed within 90 days from start of therapy.
Measured: With in the 90 days from tx start date
Late Toxicities
Any grade 3 or higher toxicity observed later than 90 days from completion of therapy.
Timepoints included below:
Approx. 90 days from tx start. Follow-Up Months (approximately from completion of treatment) 3,6,9,12,15, 18, 21, 24 (approx.) Months 30, 36 (approximately from completion of treatment) Year 4 and 5 (approximately from completion of treatment)
Measured: Every 3 months for 3 Years from the tx start date and assessed up to 133 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20104 Sep 2025

First posted10 Oct 2011 (estimated)
Study startMar 2010
Primary completionJul 2025
Study completion4 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ChordomasStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe 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: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01449149
Sponsor's protocol ID: UPCC 01310
Status last verified: Nov 2025
First submitted: 4 Oct 2011
Last updated: 5 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingObservational study
Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes
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RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum

All Chordomas trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proton Radiation For Chordomas and Chondrosarcomas
ClinicalTrials.gov ID: NCT01449149
Acronym / sponsor ID: UPCC 01310
Conditions: Chordomas, Chondrosarcomas
Keywords: Age 18 or greater, No prior radiation
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Study start: Mar 2010 (actual)
Primary completion: Jul 2025 (actual)
Study completion: 4 Sep 2025 (actual)
First posted: 10 Oct 2011 (estimated)
Results: Posted 5 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Proton group	Experimental	Radiation: Proton TherapyProton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Histologically confirmed diagnosis of chordoma or chondrosarcoma.
Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
Patients must have an ECOG score equal to or less than 2.
Age ≥ 18 years.
Patients must be able to provide informed consent.

Key exclusion criteria (5 listed)

Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
Pregnant women.
Actively being treated on any other therapeutic research study.
Tumors arising outside of the CNS.

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
Proton Therapy	Radiation	Proton group

Primary outcome

Feasibility of Proton RT for Chordomas and Chondrosarcomas
Time frame: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months
The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. The feasibility, as defined by ≥10% of patients experiencing either: unsatisfactory dosimetry, inability to complete all of his/her treatments within 10 days of estimated completion date and requiring no break >5 days, and no greater than 20% of patients experiencing ≥grade 3 toxicity from RT.

2 secondary outcomes

Acute Toxicities
Time frame: With in the 90 days from tx start date
Late Toxicities
Time frame: Every 3 months for 3 Years from the tx start date and assessed up to 133 months

Results and safety

Results posted to the registry on 5 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton Group	54	54

Primary outcome: Feasibility of Proton RT for Chordomas and Chondrosarcomas

Time frame: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months. Number. Unit: percentage of patients did not meet this

Measure	Proton Group n = 54
>10% of patients experiencing unstatisfactory dosimetry or inability to complete his/her treatments	3.7
20% of patients experienceing >= grade 3 toxicity	1.9

Population analysed: Follow-up

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton Group	15 of 54 (27.8%)	45 of 54 (83.3%)	3 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chordomas

Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes
Genes, Sporadic Chordoma
RecruitingObservational study
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Chordoma of Spine, Chordoma of Skull Base
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proton Therapy in people with Chordomas and Chondrosarcomas, run by Abramson Cancer Center at Penn Medicine at 1 site 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 5 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Proton RT for Chordomas and Chondrosarcomas (time frame: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449149.

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 5 Dec 2025.