An interventional study of Proton Therapy in Chordomas and Chondrosarcomas, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
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.
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.
68 studies on the registry are indexed under Chordoma; 15 are open to participants now.
This study's enrollment of 54 is above the median of 38 across 50 interventional studies indexed under Chordoma.
Browse Chordoma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Radiation: Proton Therapy
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.
Time frame: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months
Acute Toxicities
Any grade 3 or higher toxicity observed within 90 days from start of therapy.
Time frame: 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)
Time frame: Every 3 months for 3 Years from the tx start date and assessed up to 133 months
| Milestone | Proton Group |
|---|---|
| Started | 54 |
| Completed | 54 |
| Not completed | 0 |
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.
| percentage of patients did not meet this | Proton Group |
|---|---|
| >10% of patients experiencing unstatisfactory dosimetry or inability to complete his/her treatments | 3.7 |
| 20% of patients experienceing >= grade 3 toxicity | 1.9 |
Any grade 3 or higher toxicity observed within 90 days from start of therapy.
| Number of cases | Proton Group |
|---|---|
| Fatigue | 37 |
| Radiation dermatitis | 28 |
| Headache | 14 |
| Alopecia | 9 |
| Insomnia | 9 |
| Paresthesia | 7 |
| Constipation | 7 |
| Pain | 4 |
| Dysphagia | 6 |
| Xerostomia | 4 |
| Diarrhea | 2 |
| Anorexia | 5 |
| Urinary (retention or incontinence) | 6 |
| Ataxia | 5 |
| Oral mucositis | 2 |
| Edema | 2 |
| Visual/blurry | 2 |
| Nerve palsy | 1 |
| Tinnitus | 1 |
| Dysgeusia | 5 |
| Cognitive disturbance | 3 |
| Voice alteration | 3 |
| Dysarthria | 1 |
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)
| Number of cases | Proton Group |
|---|---|
| Late Fatigue | 17 |
| Late Headache | 8 |
| Late Pain | 4 |
| Late Loss of smell | 1 |
| Late Cognitive disturbance | 2 |
| Late Xerostomia | 1 |
| Late Paresthesia | 5 |
| Late Insomnia | 1 |
| Late Diarrhea | 1 |
| Late Neck edema | 1 |
| Late Dysgeusia | 2 |
| Late Ataxia | 5 |
| Late Aphasia | 1 |
| Late Radionecrosis of the brain | 3 |
| Late Anorexia | 2 |
| Late Dysphagia | 2 |
| Late Muscle weakness | 1 |
| Late Intranasal carotid blowout | 1 |
| Late Osteoradionecrosis | 1 |
Collected over Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton Group | 3/54 (5.6%) | 15/54 (27.8%) | 45/54 (83.3%) |
| Event | Proton Group |
|---|---|
| FatigueGeneral disorders | 4/54 |
| HeadacheNervous system disorders | 3/54 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 3/54 |
| LeukocytosisBlood and lymphatic system disorders | 2/54 |
| Skin infectionInfections and infestations | 2/54 |
| Sensory neuropathyNervous system disorders | 1/54 |
| Optic nerve disorderEye disorders | 1/54 |
| Abdominal painGastrointestinal disorders | 1/54 |
| Anorectal infectionInfections and infestations | 1/54 |
| Lymph gland infectionInfections and infestations | 1/54 |
| Event | Proton Group |
|---|---|
| FatigueGeneral disorders | 33/54 |
| Dermatitis radiationInjury, poisoning and procedural complications | 24/54 |
| NauseaGastrointestinal disorders | 15/54 |
| AnorexiaMetabolism and nutrition disorders | 15/54 |
| InsomniaPsychiatric disorders | 12/54 |
| AlopeciaSkin and subcutaneous tissue disorders | 10/54 |
| DysgeusiaNervous system disorders | 9/54 |
| HeadacheNervous system disorders | 9/54 |
| ConstipationGastrointestinal disorders | 8/54 |
| Dry mouthGastrointestinal disorders | 8/54 |
| Age, Categorical(Participants) | Proton Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 41 |
| >=65 years | 13 |
| Age, Continuous(years) | Proton Group |
|---|---|
| Median | 54 (23 to 87) |
| Sex: Female, Male(Participants) | Proton Group |
|---|---|
| Female | 32 |
| Male | 22 |
| Ethnicity (NIH/OMB)(Participants) | Proton Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 54 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Proton Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 49 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Proton Group |
|---|---|
| United States | 54 |
| Histology(Participants) | Proton Group |
|---|---|
| Chordoma | 42 |
| Chondrosarcoma | 12 |
| Lesion site(Participants) | Proton Group |
|---|---|
| Clivus/skull base | 39 |
| C spine | 3 |
| T spine | 0 |
| L spine | 1 |
| Sacrum/coccyx | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2010 to primary completion in Jul 2025, 184 months.
Results were first posted in Dec 2025, 5 months after primary completion.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine →