Trial Outcomes & Findings for Proton Radiation for Chordomas and Chondrosarcomas (NCT NCT01449149)
NCT ID: NCT01449149
Last Updated: 2025-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Proton Group
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proton Radiation for Chordomas and Chondrosarcomas
Baseline characteristics by cohort
| Measure |
Proton Group
n=54 Participants
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=37 Participants
|
|
Age, Continuous
|
54 years
n=37 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=37 Participants
|
|
Histology
Chordoma
|
42 Participants
n=37 Participants
|
|
Histology
Chondrosarcoma
|
12 Participants
n=37 Participants
|
|
Lesion site
Clivus/skull base
|
39 Participants
n=37 Participants
|
|
Lesion site
C spine
|
3 Participants
n=37 Participants
|
|
Lesion site
T spine
|
0 Participants
n=37 Participants
|
|
Lesion site
L spine
|
1 Participants
n=37 Participants
|
|
Lesion site
Sacrum/coccyx
|
11 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 monthsPopulation: Follow-up
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.
Outcome measures
| Measure |
Proton Group
n=54 Participants
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Feasibility of Proton RT for Chordomas and Chondrosarcomas
>10% of patients experiencing unstatisfactory dosimetry or inability to complete his/her treatments
|
3.7 percentage of patients did not meet this
|
|
Feasibility of Proton RT for Chordomas and Chondrosarcomas
20% of patients experienceing >= grade 3 toxicity
|
1.9 percentage of patients did not meet this
|
SECONDARY outcome
Timeframe: With in the 90 days from tx start datePopulation: Number of cases
Any grade 3 or higher toxicity observed within 90 days from start of therapy.
Outcome measures
| Measure |
Proton Group
n=54 Participants
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Acute Toxicities
Anorexia
|
5 Number of cases
|
|
Acute Toxicities
Urinary (retention or incontinence)
|
6 Number of cases
|
|
Acute Toxicities
Ataxia
|
5 Number of cases
|
|
Acute Toxicities
Oral mucositis
|
2 Number of cases
|
|
Acute Toxicities
Fatigue
|
37 Number of cases
|
|
Acute Toxicities
Radiation dermatitis
|
28 Number of cases
|
|
Acute Toxicities
Headache
|
14 Number of cases
|
|
Acute Toxicities
Alopecia
|
9 Number of cases
|
|
Acute Toxicities
Insomnia
|
9 Number of cases
|
|
Acute Toxicities
Paresthesia
|
7 Number of cases
|
|
Acute Toxicities
Constipation
|
7 Number of cases
|
|
Acute Toxicities
Pain
|
4 Number of cases
|
|
Acute Toxicities
Dysphagia
|
6 Number of cases
|
|
Acute Toxicities
Xerostomia
|
4 Number of cases
|
|
Acute Toxicities
Diarrhea
|
2 Number of cases
|
|
Acute Toxicities
Edema
|
2 Number of cases
|
|
Acute Toxicities
Visual/blurry
|
2 Number of cases
|
|
Acute Toxicities
Nerve palsy
|
1 Number of cases
|
|
Acute Toxicities
Tinnitus
|
1 Number of cases
|
|
Acute Toxicities
Dysgeusia
|
5 Number of cases
|
|
Acute Toxicities
Cognitive disturbance
|
3 Number of cases
|
|
Acute Toxicities
Voice alteration
|
3 Number of cases
|
|
Acute Toxicities
Dysarthria
|
1 Number of cases
|
SECONDARY outcome
Timeframe: Every 3 months for 3 Years from the tx start date and assessed up to 133 monthsPopulation: Number of cases
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)
Outcome measures
| Measure |
Proton Group
n=54 Participants
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Late Toxicities
Late Insomnia
|
1 Number of cases
|
|
Late Toxicities
Late Diarrhea
|
1 Number of cases
|
|
Late Toxicities
Late Neck edema
|
1 Number of cases
|
|
Late Toxicities
Late Dysgeusia
|
2 Number of cases
|
|
Late Toxicities
Late Ataxia
|
5 Number of cases
|
|
Late Toxicities
Late Aphasia
|
1 Number of cases
|
|
Late Toxicities
Late Intranasal carotid blowout
|
1 Number of cases
|
|
Late Toxicities
Late Osteoradionecrosis
|
1 Number of cases
|
|
Late Toxicities
Late Paresthesia
|
5 Number of cases
|
|
Late Toxicities
Late Headache
|
8 Number of cases
|
|
Late Toxicities
Late Pain
|
4 Number of cases
|
|
Late Toxicities
Late Loss of smell
|
1 Number of cases
|
|
Late Toxicities
Late Radionecrosis of the brain
|
3 Number of cases
|
|
Late Toxicities
Late Anorexia
|
2 Number of cases
|
|
Late Toxicities
Late Dysphagia
|
2 Number of cases
|
|
Late Toxicities
Late Muscle weakness
|
1 Number of cases
|
|
Late Toxicities
Late Fatigue
|
17 Number of cases
|
|
Late Toxicities
Late Cognitive disturbance
|
2 Number of cases
|
|
Late Toxicities
Late Xerostomia
|
1 Number of cases
|
Adverse Events
Proton Group
Serious events: 15 serious events
Other events: 45 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Proton Group
n=54 participants at risk
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Nervous system disorders
Sensory neuropathy
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Optic nerve disorder
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Fatigue
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Anorectal infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Lymph gland infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Otitis media
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Skin infection
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Investigations
Weight loss
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Edema cerebral
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
3/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
Other adverse events
| Measure |
Proton Group
n=54 participants at risk
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Proton Therapy
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Investigations
Platelet count decreased
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Investigations
Weight loss
|
11.1%
6/54 • Number of events 6 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.8%
15/54 • Number of events 20 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
3/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Abducens nerve disorder
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Amnesia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Ataxia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Cognitive disturbance
|
7.4%
4/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Dizziness
|
9.3%
5/54 • Number of events 6 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Dysarthria
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Dysesthesia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
9/54 • Number of events 9 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Dysphasia
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Facial muscle weakness
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Headache
|
16.7%
9/54 • Number of events 17 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Memory impairment
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Paresthesia
|
13.0%
7/54 • Number of events 7 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Sinus pain
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Stroke
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Nervous system disorders
Tremor
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Anxiety
|
9.3%
5/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Depression
|
13.0%
7/54 • Number of events 8 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Insomnia
|
22.2%
12/54 • Number of events 13 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Personality change
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Hematuria
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Urinary frequency
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Renal and urinary disorders
Urinary urgency
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
3.7%
2/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
4/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.5%
10/54 • Number of events 10 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
6/54 • Number of events 6 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.3%
5/54 • Number of events 6 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Vascular disorders
Hypertension
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Watering eyes
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
3/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Bloating
|
9.3%
5/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
8/54 • Number of events 8 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
6/54 • Number of events 8 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Dry mouth
|
14.8%
8/54 • Number of events 11 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Dysphagia
|
14.8%
8/54 • Number of events 11 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.4%
4/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Nausea
|
27.8%
15/54 • Number of events 20 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Rectal pain
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
6/54 • Number of events 8 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Edema face
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Facial pain
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Fatigue
|
61.1%
33/54 • Number of events 47 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Flu like symptoms
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Irritability
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
General disorders
Pain
|
5.6%
3/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Mucosal infection
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Otitis media
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
44.4%
24/54 • Number of events 32 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.9%
1/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Ear and labyrinth disorders
Ear pain
|
9.3%
5/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Ear and labyrinth disorders
External ear pain
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
6/54 • Number of events 7 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.3%
5/54 • Number of events 5 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Blurred vision
|
5.6%
3/54 • Number of events 3 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Dry eye
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Eye disorders - Other, specify
|
7.4%
4/54 • Number of events 4 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Eye pain
|
3.7%
2/54 • Number of events 2 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
|
Eye disorders
Eyelid function disorder
|
1.9%
1/54 • Number of events 1 • Acute and late toxicities were assessed for a time frame of over 133 months at 3-month intervals.
|
Additional Information
Michelle Alonso-Basanta, MD PhD
Department of Radiation Oncology, PENN MEDICINE
Phone: 215 615 3782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place