Trial Outcomes & Findings for Phase II Trial Evaluating Elimination of Radiation Therapy (NCT NCT00593840)
NCT ID: NCT00593840
Last Updated: 2025-05-11
Results Overview
* Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
12 months of follow-up
Results posted on
2025-05-11
Participant Flow
The study opened to accrual on 04/11/2007 and closed to accrual 04/07/2014.
Participant milestones
| Measure |
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Trial Evaluating Elimination of Radiation Therapy
Baseline characteristics by cohort
| Measure |
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
n=73 Participants
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
|
Primary tumor type
Oropharynx
|
37 participants
n=5 Participants
|
|
Primary tumor type
Larynx
|
17 participants
n=5 Participants
|
|
Primary tumor type
Oral cavity
|
14 participants
n=5 Participants
|
|
Primary tumor type
Hypopharynx
|
4 participants
n=5 Participants
|
|
Primary tumor type
Unknown
|
1 participants
n=5 Participants
|
|
Tobacco abuse
Yes
|
47 participants
n=5 Participants
|
|
Tobacco abuse
No
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months of follow-up* Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.
Outcome measures
| Measure |
Arm 1: IMRT
n=72 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Number of Participants With a Recurrence in the Unirradiated Neck(s)
|
0 participants
Interval 0.0 to 4.2
|
SECONDARY outcome
Timeframe: 3 years* Recurrence is defined as the return of cancer after treatment * Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame
Outcome measures
| Measure |
Arm 1: IMRT
n=34 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
|
88.6 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Median follow-up was 22 monthsPopulation: 65 out of 73 patients had evaluable QOL data in Arm 1.
-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
Outcome measures
| Measure |
Arm 1: IMRT
n=65 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Quality of Life (QOL) as Measured by Overall Global QOL Scores
|
59.1410 units on a scale
Standard Deviation 34.8294
|
SECONDARY outcome
Timeframe: Median follow-up was 22 months-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
Outcome measures
| Measure |
Arm 1: IMRT
n=65 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Quality of Life (QOL) as Measured by Xerostomia QOL Data
|
39.5584 units on a scale
Standard Deviation 26.0941
|
SECONDARY outcome
Timeframe: Completion of follow-up (minimum of 5 years from completion of treatment)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of follow-up (minimum of 5 years from completion of treatment)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Arm 1: IMRT
n=45 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Kaplan Meier Estimate of Overall Survival
|
75.8 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Completion of follow-up (minimum of 5 years from completion of treatment)For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 3 years-Recurrence is defined as the return of cancer after treatment
Outcome measures
| Measure |
Arm 1: IMRT
n=31 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Kaplan Meier Estimate of Regional Recurrence Free Survival
|
94.8 percentage of participants-Kaplan Meier
|
POST_HOC outcome
Timeframe: 3 years-Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1: IMRT
n=49 Participants
CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions
|
|---|---|
|
Kaplan Meier Estimate of Progression-free Survival
|
68.9 percentage of participants-Kaplan Meier
|
Adverse Events
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
Serious events: 7 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
n=72 participants at risk
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
|
|---|---|
|
General disorders
Death NOS
|
1.4%
1/72
|
|
General disorders
Edema: head and neck
|
1.4%
1/72
|
|
Gastrointestinal disorders
Nausea
|
5.6%
4/72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
3/72
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72
|
|
Gastrointestinal disorders
Dyspnea
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/72
|
|
Psychiatric disorders
Confusion
|
2.8%
2/72
|
|
Psychiatric disorders
Psychosis
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.8%
2/72
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/72
|
|
Investigations
Platelets
|
1.4%
1/72
|
|
General disorders
Fever
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/72
|
|
Infections and infestations
Infection - catheter
|
1.4%
1/72
|
|
Gastrointestinal disorders
Mucositis - oral cavity
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Rash (erythema)
|
1.4%
1/72
|
|
Vascular disorders
Hematoma
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
2/72
|
|
Musculoskeletal and connective tissue disorders
Oral cavity pain
|
1.4%
1/72
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/72
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.4%
1/72
|
|
General disorders
Generalized weakness
|
1.4%
1/72
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/72
|
Other adverse events
| Measure |
Arm 1: Intensity Modulated Radiation Therapy (IMRT)
n=72 participants at risk
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
|
|---|---|
|
Investigations
ALT, SGPT
|
1.4%
1/72
|
|
Investigations
ALT, SGPT (late radiation morbidity)
|
5.6%
4/72
|
|
Investigations
ANC/Neutrophils (late radiation morbidity)
|
1.4%
1/72
|
|
Investigations
AST, SGOT
|
1.4%
1/72
|
|
Investigations
AST, SGOT (late radiation morbidity)
|
4.2%
3/72
|
|
Gastrointestinal disorders
Abdomen pain (late radiation morbidity)
|
5.6%
4/72
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Albumin (late radiation morbidity)
|
8.3%
6/72
|
|
Metabolism and nutrition disorders
Albumin, serum-low
|
4.2%
3/72
|
|
Investigations
Alkaline phosphatase
|
2.8%
2/72
|
|
Immune system disorders
Allergic rhinitis
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Anorexia
|
9.7%
7/72
|
|
Metabolism and nutrition disorders
Anorexia (late radiation morbidity)
|
2.8%
2/72
|
|
Nervous system disorders
Apnea (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Arm pain (late radiation morbidity)
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia secondary to squamous cell carcinoma (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Back pain (late radiation morbidity)
|
5.6%
4/72
|
|
Investigations
Bilirubin (late radiation morbidity)
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Calcium, serum-high
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Calcium, serum-low
|
11.1%
8/72
|
|
Metabolism and nutrition disorders
Calcium, serum-low (late radiation morbidity)
|
2.8%
2/72
|
|
Cardiac disorders
Cardiac arrest (late radiation morbidity)
|
1.4%
1/72
|
|
Cardiac disorders
Chest pain
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thorax NOS pain (late radiation morbidity)
|
2.8%
2/72
|
|
Respiratory, thoracic and mediastinal disorders
Clavicle pain (late radiation morbidity)
|
1.4%
1/72
|
|
Nervous system disorders
Cognitive disturbance (late radiation morbidity)
|
1.4%
1/72
|
|
Psychiatric disorders
Confusion (late radiation morbidity)
|
2.8%
2/72
|
|
Gastrointestinal disorders
Constipation
|
8.3%
6/72
|
|
Gastrointestinal disorders
Constipation (late radiation morbidity)
|
5.6%
4/72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
3/72
|
|
Respiratory, thoracic and mediastinal disorders
Cough (late radiation morbidity)
|
11.1%
8/72
|
|
Investigations
Creatinine
|
5.6%
4/72
|
|
Investigations
Creatinine (late radiation morbidity)
|
1.4%
1/72
|
|
General disorders
Death NOS (late radiation morbidity)
|
2.8%
2/72
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
4/72
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
4/72
|
|
Gastrointestinal disorders
Diarrhea (late radiation morbidity)
|
5.6%
4/72
|
|
Nervous system disorders
Dizziness
|
1.4%
1/72
|
|
Nervous system disorders
Dizziness (late radiation morbidity)
|
2.8%
2/72
|
|
Gastrointestinal disorders
Dry mouth (late radiation morbidity)
|
38.9%
28/72
|
|
Gastrointestinal disorders
Dry mouth/salivary gland
|
31.9%
23/72
|
|
Gastrointestinal disorders
Dysphagia
|
45.8%
33/72
|
|
Gastrointestinal disorders
Dysphagia (late radiation morbidity)
|
36.1%
26/72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
2/72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (late radiation morbidity)
|
4.2%
3/72
|
|
Ear and labyrinth disorders
Ear hemorrhage/bleeding
|
1.4%
1/72
|
|
Ear and labyrinth disorders
Ear pain (late radiation morbidity)
|
1.4%
1/72
|
|
General disorders
Edema: head and neck
|
29.2%
21/72
|
|
General disorders
Edema: head and neck (late radiation morbidity)
|
25.0%
18/72
|
|
Respiratory, thoracic and mediastinal disorders
Edema: larynx
|
4.2%
3/72
|
|
General disorders
Edema: limb (late radiation morbidity)
|
1.4%
1/72
|
|
General disorders
Edema: oropharynx
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Erythema (late radiation morbidity)
|
4.2%
3/72
|
|
Gastrointestinal disorders
Esophagitis
|
2.8%
2/72
|
|
Musculoskeletal and connective tissue disorders
Face pain (late radiation morbidity)
|
1.4%
1/72
|
|
General disorders
Failure to thrive
|
1.4%
1/72
|
|
General disorders
Fatigue
|
25.0%
18/72
|
|
General disorders
Fatigue (late radiation morbidity)
|
16.7%
12/72
|
|
General disorders
Fever
|
4.2%
3/72
|
|
General disorders
Fever (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Fistula (late radiation morbidity)
|
1.4%
1/72
|
|
General disorders
Generalized pain
|
12.5%
9/72
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
4.2%
3/72
|
|
Metabolism and nutrition disorders
Glucose, serum-high (late radiation morbidity)
|
4.2%
3/72
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
5.6%
4/72
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (late radiation morbidity)
|
2.8%
2/72
|
|
Nervous system disorders
Headache
|
1.4%
1/72
|
|
Nervous system disorders
Headache (late radiation morbidity)
|
5.6%
4/72
|
|
Ear and labyrinth disorders
Hearing
|
4.2%
3/72
|
|
Ear and labyrinth disorders
Hearing (late radiation morbidity)
|
6.9%
5/72
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.8%
2/72
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
24/72
|
|
Blood and lymphatic system disorders
Hemoglobin (late radiation morbidity)
|
19.4%
14/72
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory (late radiation morbidity)
|
2.8%
2/72
|
|
Gastrointestinal disorders
Hemorrhage, oral cavity (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Hemorrhoids (late radiation morbidity)
|
1.4%
1/72
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
4.2%
3/72
|
|
Vascular disorders
Hypertension (late radiation morbidity)
|
1.4%
1/72
|
|
Vascular disorders
Hypotension
|
1.4%
1/72
|
|
Investigations
INR
|
1.4%
1/72
|
|
Investigations
INR (late radiation morbidity)
|
8.3%
6/72
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (late radiation morbidity)
|
2.8%
2/72
|
|
Infections and infestations
Infection with normal ANC or grade 1 or 2 neutrophils
|
2.8%
2/72
|
|
Psychiatric disorders
Insomnia (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Jaw pain (late radiation morbidity)
|
4.2%
3/72
|
|
Musculoskeletal and connective tissue disorders
Joint function (stiff)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
1.4%
1/72
|
|
Investigations
Leukocytes (late radiation morbidity)
|
5.6%
4/72
|
|
Investigations
Leukocytes (total WBC)
|
23.6%
17/72
|
|
Reproductive system and breast disorders
Libido (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Limb pain (late radiation morbidity)
|
1.4%
1/72
|
|
Investigations
Lymphopenia
|
37.5%
27/72
|
|
Investigations
Lymphopenia (late radiation morbidity)
|
23.6%
17/72
|
|
Metabolism and nutrition disorders
Magnesium, serum-low
|
1.4%
1/72
|
|
General disorders
Metastatic disease (late radiation morbidity)
|
5.6%
4/72
|
|
Psychiatric disorders
Mood alteration: anxiety
|
4.2%
3/72
|
|
Psychiatric disorders
Mood alteration: anxiety (late radiation morbidity)
|
2.8%
2/72
|
|
Psychiatric disorders
Mood alteration: depression
|
9.7%
7/72
|
|
Psychiatric disorders
Mood alteration: depression (late radiation morbidity)
|
8.3%
6/72
|
|
Infections and infestations
Mouth (thrush) infection (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Mucositis (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Mucositis - oral cavity
|
56.9%
41/72
|
|
Gastrointestinal disorders
Mucositis - oropharynx
|
6.9%
5/72
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional)
|
16.7%
12/72
|
|
Gastrointestinal disorders
Mucositis/stomatitis - oral cavity (late radiation morbidity)
|
11.1%
8/72
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area
|
1.4%
1/72
|
|
Gastrointestinal disorders
Nausea
|
31.9%
23/72
|
|
Gastrointestinal disorders
Nausea (late radiation morbidity)
|
9.7%
7/72
|
|
Gastrointestinal disorders
Neck fistula (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.3%
11/72
|
|
Musculoskeletal and connective tissue disorders
Neck pain (late radiation morbidity)
|
19.4%
14/72
|
|
Nervous system disorders
Neuropathy: motor
|
1.4%
1/72
|
|
Nervous system disorders
Neuropathy: sensory
|
6.9%
5/72
|
|
Nervous system disorders
Neuropathy: sensory (late radiation morbidity)
|
5.6%
4/72
|
|
Investigations
Neutrophils/Granulocytes
|
12.5%
9/72
|
|
Gastrointestinal disorders
Obstruction (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Oral cavity fibrosis (tongue) (late radiation morbidity)
|
2.8%
2/72
|
|
Gastrointestinal disorders
Oral cavity pain
|
15.3%
11/72
|
|
Gastrointestinal disorders
Oral cavity pain (late radiation morbidity)
|
5.6%
4/72
|
|
Respiratory, thoracic and mediastinal disorders
Oropharynx pain
|
6.9%
5/72
|
|
Musculoskeletal and connective tissue disorders
Osteoradionecrosis (late radiation morbidity)
|
1.4%
1/72
|
|
Investigations
PTT (late radiation morbidity)
|
1.4%
1/72
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Pharynx pain
|
4.2%
3/72
|
|
Investigations
Platelets
|
9.7%
7/72
|
|
Investigations
Platelets (late radiation morbidity)
|
2.8%
2/72
|
|
Infections and infestations
Pneumonia
|
4.2%
3/72
|
|
Infections and infestations
Pneumonia (late radiation morbidity)
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Potassium (late radiation morbidity)
|
6.9%
5/72
|
|
Metabolism and nutrition disorders
Potassium, serum-high
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Potassium, serum-low (late radiation morbidity)
|
2.8%
2/72
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/72
|
|
Injury, poisoning and procedural complications
Radiation changes - pharynx/esophagus
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Rash - dermatitis (late radiation morbidity)
|
11.1%
8/72
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.1%
8/72
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
4.2%
3/72
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.4%
1/72
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation
|
31.9%
23/72
|
|
Investigations
Rigors/chills (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Salivary gland changes, saliva (late radiation morbidity)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
20.8%
15/72
|
|
Gastrointestinal disorders
Salivary glands (late radiation morbidity)
|
4.2%
3/72
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain (late radiation morbidity)
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Skin (late radiation morbidity)
|
4.2%
3/72
|
|
Skin and subcutaneous tissue disorders
Skin changes
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Skin tightness (late radiation morbidity)
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Sodium, serum-high (late radiation morbidity)
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Sodium, serum-low
|
2.8%
2/72
|
|
Metabolism and nutrition disorders
Sodium, serum-low (late radiation morbidity)
|
5.6%
4/72
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
2.8%
2/72
|
|
Nervous system disorders
Speech impairment
|
6.9%
5/72
|
|
Nervous system disorders
Speech impairment (late radiation morbidity)
|
1.4%
1/72
|
|
Nervous system disorders
Syncope (late radiation morbidity)
|
2.8%
2/72
|
|
Gastrointestinal disorders
Taste alteration
|
31.9%
23/72
|
|
Gastrointestinal disorders
Teeth discoloration (late radiation morbidity)
|
1.4%
1/72
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Throat/larynx pain
|
9.7%
7/72
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx pain (late radiation morbidity)
|
9.7%
7/72
|
|
Vascular disorders
Thrombosis/thrombus/embolism (late radiation morbidity)
|
1.4%
1/72
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
4/72
|
|
Gastrointestinal disorders
Tongue pain (late radiation morbidity)
|
1.4%
1/72
|
|
Infections and infestations
Tracheitis (late radiation morbidity)
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Trismus (late radiation morbidity)
|
4.2%
3/72
|
|
Infections and infestations
Upper respiratory infection (late radiation morbidity)
|
1.4%
1/72
|
|
Eye disorders
Vision-blurred vision (late radiation morbidity)
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
23.6%
17/72
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (late radiation morbidity)
|
18.1%
13/72
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
16/72
|
|
Gastrointestinal disorders
Vomiting (late radiation morbidity)
|
6.9%
5/72
|
|
Eye disorders
Watery eye
|
2.8%
2/72
|
|
Investigations
Weight gain
|
1.4%
1/72
|
|
Investigations
Weight loss
|
33.3%
24/72
|
|
General disorders
Weight loss (late radiation morbidity)
|
11.1%
8/72
|
|
Injury, poisoning and procedural complications
Wound complication, non infectious (late radiation morbidity)
|
1.4%
1/72
|
Additional Information
Wade Thorstad, M.D.
Washington University School of Medicine
Phone: 314-362-8516
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place