Trial Outcomes & Findings for Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx (NCT NCT01088802)
NCT ID: NCT01088802
Last Updated: 2022-11-08
Results Overview
The goal is to achieve a prevalence of \< 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2022-11-08
Participant Flow
Patients were recruited from Johns Hopkins' Radiation/Medical Oncology clinics from 2010-2016.
Participant milestones
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
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|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
Baseline characteristics by cohort
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=60 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
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|---|---|
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Age, Continuous
|
59.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white/caucasian
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black/african american
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic/latino
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 5/60 patients did not have adverse event data captured for the period.
The goal is to achieve a prevalence of \< 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events.
Outcome measures
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=55 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
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|---|---|
|
Percentage of Patients Free of Grade 3+ Late Toxicity
|
86 percentage of participants
Interval 82.0 to 97.0
|
PRIMARY outcome
Timeframe: 2 yearsLocoregional tumor control \> 85 + or - 7% at 2 years; measured through progression-free survival (the time from assignment in a clinical trial to disease progression or death from any cause). Locoregional tumor control is reported as percentage of patients meeting this criteria.
Outcome measures
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=60 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
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|---|---|
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Percentage of Patients With Locoregional Tumor Control
|
92 percentage of participants
Interval 85.0 to 99.0
|
PRIMARY outcome
Timeframe: Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5Population: Data was not collected to assess this outcome.
To determine the nature and prevalence of side effects at different time intervals and describe their relationship to pretreatment function and local dose and treated volume.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, 6 months, 1 year, 2 years, 3 years, 4-5 year visitPopulation: Some patients did not respond to QoL assessment for the various time points.
Determine quality of life of surviving patients measured by patient reported outcomes: -MDADI-Self-administered assessment on patient swallowing ability. There are 19 questions specific to swallowing that study patients completed. Composite score is the average of the 19 questions. The scale is 20 (extremely low functioning) to 100 (high functioning). Composite score is reported.
Outcome measures
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=48 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
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|---|---|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
Baseline
|
87.71 score on a scale
Standard Deviation 13.72
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
6-8 week visit
|
77.75 score on a scale
Standard Deviation 13.42
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
6 month visit
|
78.62 score on a scale
Standard Deviation 13.45
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
1 year visit
|
86.18 score on a scale
Standard Deviation 11.86
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
2 year visit
|
87.64 score on a scale
Standard Deviation 11.35
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
3 year visit
|
88.16 score on a scale
Standard Deviation 9.68
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
4-5 year visit
|
89.48 score on a scale
Standard Deviation 9.62
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visitPopulation: Some patients did not respond to QoL assessment for the various time points.
Determine quality of life of surviving patients measured by patient reported outcomes: MDASI-HN-Self-reported assessment. Measures symptom severity in previous day. Study patients answered 9 specific questions specific to head and neck cancer. Symptom severity scores, from 0 (not present) to 10 (worst possible). Composite score calculated average of individual scores. Mean module (head and neck) symptom severity is reported.
Outcome measures
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=56 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
|
|---|---|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
baseline
|
0.45 score on a scale
Standard Deviation 0.6
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
6-8 week visit
|
4.17 score on a scale
Standard Deviation 1.97
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
1 year visit
|
1.06 score on a scale
Standard Deviation 1.07
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
2 year visit
|
0.98 score on a scale
Standard Deviation 1.05
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
3 year visit
|
0.92 score on a scale
Standard Deviation 1.02
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
4-5 year visit
|
0.9 score on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visitPopulation: Some patients did not respond to QoL assessment for the various time points.
Determine quality of life of surviving patients measured by patient reported outcomes: XQ measures severity of radiation-induced xerostomia and patient reported quality of life. 8 question total:4 on dryness while eating/chewing, 4 on dryness when not eating/chewing. 0-10 (higher scores=severe dryness/discomfort). Composite Scores range from 0 (no xerostomia) -100 (highest level of xerostomia).
Outcome measures
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=56 Participants
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
|
|---|---|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
6-8 week visit
|
6.23 score on a scale
Standard Deviation 3.24
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
baseline
|
0.65 score on a scale
Standard Deviation 0.89
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
1 year visit
|
3.27 score on a scale
Standard Deviation 2.26
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
2 year visit
|
2.96 score on a scale
Standard Deviation 2.16
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
3 year visit
|
2.87 score on a scale
Standard Deviation 1.96
|
|
Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
4-5 year visit
|
2.67 score on a scale
Standard Deviation 2.05
|
Adverse Events
Dose De-escalating Radiation Therapy With Chemotherapy
Serious events: 54 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=60 participants at risk
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Nervous system disorders
akathisia
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
ANC decreased
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
anorexia
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Cardiac disorders
atrial fibrillation
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
colonic obstruction
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
constipation
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
dehydration
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
diarrhea
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
dysphagia
|
6.7%
4/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
edema limbs
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Infections and infestations
enterocolitis infectious
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
Esophageal stricture
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
fatigue
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
6.7%
4/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
fever
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
flatulence
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
general NOS: failure to thrive
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Ear and labyrinth disorders
hearing changes
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
Hypertension
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury/procedure complication: bleeding at PEG site
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury/procedure complication: g-tube dysfunction
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury/procedure complication: PEG dysfunction
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury/procedure complication-NOS: admitted following left neck dissection
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury/procedure complication-NOS: PEG insertion
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
lower GI hemorrhage
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung metastases
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
lymphocytes decreased
|
38.3%
23/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
mucositis
|
46.7%
28/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
Mucous membrane
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
oral pain
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
pain
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
pain due to XRT
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
Pain NCI
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
pharyngeal pain
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Psychiatric disorders
psych NOS
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Psychiatric disorders
restlessness
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
saliva/salivary gland
|
18.3%
11/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Infections and infestations
skin infection
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous tissue
|
3.3%
2/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
vascular access complication
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Vascular disorders
venous thrombosis
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
WBC Decreased
|
6.7%
4/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
Xerostomia
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
Neutrophils decreased
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
pain
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Psychiatric disorders
PsychNOS: mood disorder
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
injury to carotid artery
|
1.7%
1/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
Other adverse events
| Measure |
Dose De-escalating Radiation Therapy With Chemotherapy
n=60 participants at risk
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
|
|---|---|
|
Investigations
ALT increased
|
36.7%
22/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Blood and lymphatic system disorders
anemia
|
11.7%
7/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
28.3%
17/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
AST increased
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
bilirubin increased
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
20/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
creatinine increased
|
20.0%
12/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
dehydration
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
dermal caries
|
16.7%
10/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
46.7%
28/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Nervous system disorders
dysgeusia
|
68.3%
41/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
dysphagia
|
23.3%
14/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
esophageal stenosis
|
13.3%
8/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
esophagus/RTOG
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
General disorders
fatigue
|
36.7%
22/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Ear and labyrinth disorders
hearing changes
|
6.7%
4/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
15.0%
9/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
13.3%
8/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hypomagnesia
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
hyponatremia
|
31.7%
19/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
larynx/RTOG
|
13.3%
8/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
mucositis
|
35.0%
21/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
mucous membrane/RTOG
|
18.3%
11/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
nausea
|
31.7%
19/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Injury, poisoning and procedural complications
pain due to XRT
|
53.3%
32/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
platelets/count decreased
|
48.3%
29/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
saliva/salivary gland
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
skin acute
|
71.7%
43/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
skin late
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
subcutaneous tissue/RTOG
|
56.7%
34/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Ear and labyrinth disorders
tinnitus
|
11.7%
7/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Musculoskeletal and connective tissue disorders
trismus
|
21.7%
13/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
voice changes/alteration
|
63.3%
38/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
vomiting
|
6.7%
4/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Eye disorders
watery eye
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
WBC decreased
|
25.0%
15/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
weight loss
|
21.7%
13/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
xerostomia
|
88.3%
53/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Metabolism and nutrition disorders
anorexia
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
esophagitis
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
esophagus/RTOC
|
13.3%
8/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Ear and labyrinth disorders
hearing changes/impairment
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
lymphocytes decreased
|
10.0%
6/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Nervous system disorders
neuralgia
|
5.0%
3/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Investigations
neutrophil count decreased
|
8.3%
5/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Gastrointestinal disorders
salivary gland
|
80.0%
48/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Skin and subcutaneous tissue disorders
subcutaneous tissue
|
21.7%
13/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
11.7%
7/60 • Up to 60 months after treatment
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place