Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton group | Experimental | Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicities | Any grade 3 or higher toxicity observed within 90 days from start of therapy. | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Proton Group | Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions Proton Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Proton Group | Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions Proton Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Follow-up | Posted | Number | percentage of patients did not meet this | From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months |
|
Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Group | Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions Proton Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensory neuropathy | Nervous system disorders | NCI v4.01 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI v4.01 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Alonso-Basanta, MD PhD | Department of Radiation Oncology, PENN MEDICINE | 215 615 3782 | michelleab@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2014 | Jul 23, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002817 | Chordoma |
| D002813 | Chondrosarcoma |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Every 3 months for 3 Years from the tx start date and assessed up to 133 months |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Histology | Count of Participants | Participants |
|
| Lesion site | Count of Participants | Participants |
|
|
|
| Secondary | Acute Toxicities | Any grade 3 or higher toxicity observed within 90 days from start of therapy. | Number of cases | Posted | Number | Number of cases | With in the 90 days from tx start date |
|
|
|
| Secondary | 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) | Number of cases | Posted | Number | Number of cases | Every 3 months for 3 Years from the tx start date and assessed up to 133 months |
|
|
|
| 3 |
| 54 |
| 15 |
| 54 |
| 45 |
| 54 |
| Leukocytosis | Blood and lymphatic system disorders | NCI v4.01 | Systematic Assessment |
|
| Optic nerve disorder | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Fatigue | General disorders | NCI v4.01 | Systematic Assessment |
|
| Anorectal infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Lymph gland infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Otitis media | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Sepsis | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Skin infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Wound infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Weight loss | Investigations | NCI v4.01 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI v4.01 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI v4.01 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI v4.01 | Systematic Assessment |
|
| Edema cerebral | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Headache | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Syncope | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | NCI v4.01 | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | NCI v4.01 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | NCI v4.01 | Systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | NCI v4.01 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | NCI v4.01 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | NCI v4.01 | Systematic Assessment |
|
| Blurred vision | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Dry eye | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Eye pain | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Eyelid function disorder | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Watering eyes | Eye disorders | NCI v4.01 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI v4.01 | Systematic Assessment |
|
| Edema face | General disorders | NCI v4.01 | Systematic Assessment |
|
| Facial pain | General disorders | NCI v4.01 | Systematic Assessment |
|
| Fatigue | General disorders | NCI v4.01 | Systematic Assessment |
|
| Fever | General disorders | NCI v4.01 | Systematic Assessment |
|
| Flu like symptoms | General disorders | NCI v4.01 | Systematic Assessment |
|
| Irritability | General disorders | NCI v4.01 | Systematic Assessment |
|
| Pain | General disorders | NCI v4.01 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | NCI v4.01 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Otitis media | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Skin infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Wound infection | Infections and infestations | NCI v4.01 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | NCI v4.01 | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | NCI v4.01 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | NCI v4.01 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | NCI v4.01 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | NCI v4.01 | Systematic Assessment |
|
| Platelet count decreased | Investigations | NCI v4.01 | Systematic Assessment |
|
| Weight loss | Investigations | NCI v4.01 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI v4.01 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI v4.01 | Systematic Assessment |
|
| Abducens nerve disorder | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Facial muscle weakness | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Headache | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Sinus pain | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Stroke | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Tremor | Nervous system disorders | NCI v4.01 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Depression | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Personality change | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Psychiatric disorders - Other, specify | Psychiatric disorders | NCI v4.01 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | NCI v4.01 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | NCI v4.01 | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | NCI v4.01 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | NCI v4.01 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Periorbital edema | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | NCI v4.01 | Systematic Assessment |
|
| Hypertension | Vascular disorders | NCI v4.01 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | NCI v4.01 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| Alopecia |
|
| Insomnia |
|
| Paresthesia |
|
| Constipation |
|
| Pain |
|
| Dysphagia |
|
| Xerostomia |
|
| Diarrhea |
|
| Anorexia |
|
| Urinary (retention or incontinence) |
|
| Ataxia |
|
| Oral mucositis |
|
| Edema |
|
| Visual/blurry |
|
| Nerve palsy |
|
| Tinnitus |
|
| Dysgeusia |
|
| Cognitive disturbance |
|
| Voice alteration |
|
| Dysarthria |
|
| Title | Measurements |
|---|---|
|
| Late Loss of smell |
|
| Late Cognitive disturbance |
|
| Late Xerostomia |
|
| Late Paresthesia |
|
| Late Insomnia |
|
| Late Diarrhea |
|
| Late Neck edema |
|
| Late Dysgeusia |
|
| Late Ataxia |
|
| Late Aphasia |
|
| Late Radionecrosis of the brain |
|
| Late Anorexia |
|
| Late Dysphagia |
|
| Late Muscle weakness |
|
| Late Intranasal carotid blowout |
|
| Late Osteoradionecrosis |
|