Trial Outcomes & Findings for INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy (NCT NCT03953976)
NCT ID: NCT03953976
Last Updated: 2026-02-19
Results Overview
Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
2 years
Results posted on
2026-02-19
Participant Flow
Participant milestones
| Measure |
INRT
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
Baseline characteristics by cohort
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Age, Continuous
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
|
Disease Site
p16+ Oropharynx
|
43 Participants
n=4 Participants
|
|
Disease Site
p16- oropharynx
|
5 Participants
n=4 Participants
|
|
Disease Site
Larynx/hypopharynx
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDefinition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Locoregional Recurrence
|
11 percentage of participants
|
|
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Local Recurrence
|
9 percentage of participants
|
|
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Regional Recurrence
|
3 percentage of participants
|
|
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Distant Metastasis
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 48 patients were analyzed for oropharynx disease site; 19 patients were analyzed for larynx/hypopharynx disease site
OS= Overall survival PFS= Progression-free survival
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Comparison of SEVR Risks by Anatomic Site
OS Oropharynx
|
96 percentage probability of 2-year OS/PFS
|
|
Comparison of SEVR Risks by Anatomic Site
OS Larynx/hypopharynx
|
79 percentage probability of 2-year OS/PFS
|
|
Comparison of SEVR Risks by Anatomic Site
PFS Oropharynx
|
90 percentage probability of 2-year OS/PFS
|
|
Comparison of SEVR Risks by Anatomic Site
PFS Larynx/hypopharynx
|
63 percentage probability of 2-year OS/PFS
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 24 monthsThe EORTC QLQ-C30 is a 30-item instrument (30 questions). Results are calculated from the means of the scores from the summary score and the functional QLQ-C30 scales. Higher scores indicate better quality of life, on a scale from 0 to 100. Patients answer questions that are grouped into the following scales: Summary score (scored from 0-100, with higher scores indicating a better quality of life) -Global (Patients rate overall health and quality of life) Functional scales (each of these is scored from 0-100, with higher scores indicating a better quality of life) * Physical function (ability to perform physical tasks) * Role function (ability to perform daily and work-related activities) * Emotional function (whether patient is experiencing distress, anxiety, depression) * Cognitive function (memory, concentration) * Social function (ability to maintain social activities and relationships)
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Global Baseline
|
76.9 score on a scale
Standard Error 2.5
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Global 3M
|
80.7 score on a scale
Standard Error 2.4
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Global 6M
|
85.6 score on a scale
Standard Error 2.2
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Global 12M
|
84.5 score on a scale
Standard Error 2.2
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Global 24M
|
87.5 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Physical fcn baseline
|
92.7 score on a scale
Standard Error 1.7
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Physical fcn 3M
|
89.9 score on a scale
Standard Error 1.9
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Physical fcn 6M
|
94.2 score on a scale
Standard Error 1.8
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Physical fcn 12M
|
94.5 score on a scale
Standard Error 1.6
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Physical fcn 24M
|
96.9 score on a scale
Standard Error 1.3
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Role fcn baseline
|
91.4 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Role fcn 3M
|
86.7 score on a scale
Standard Error 2.9
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Role fcn 6M
|
94.6 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Role fcn 12M
|
94.4 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Role fcn 24M
|
97.5 score on a scale
Standard Error 1.3
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Emotional fcn baseline
|
84.6 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Emotional fcn 3M
|
88.2 score on a scale
Standard Error 2.4
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Emotional fcn 6M
|
88.6 score on a scale
Standard Error 2.5
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Emotional fcn 12M
|
88.3 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Emotional fcn 24M
|
92.3 score on a scale
Standard Error 1.7
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Cognitive fcn baseline
|
92.0 score on a scale
Standard Error 1.5
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Cognitive fcn 3M
|
88.6 score on a scale
Standard Error 2.3
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Cognitive fcn 6M
|
88.5 score on a scale
Standard Error 2.4
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Cognitive fcn 12M
|
86.9 score on a scale
Standard Error 2.3
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Cognitive fcn 24M
|
92.9 score on a scale
Standard Error 1.7
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Social fcn baseline
|
89.1 score on a scale
Standard Error 2.2
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Social fcn 3M
|
88.6 score on a scale
Standard Error 2.7
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Social fcn 6M
|
93.0 score on a scale
Standard Error 1.9
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Social fcn 12M
|
93.0 score on a scale
Standard Error 1.9
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
Social fcn 24M
|
97.1 score on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 6 month, 12 month, 24 monthsPatients report to which extent they experience symptoms or problems during one week. EORTC HN35 subscales are each scored on a scale from 0 to 100, with higher scores indicating worse symptoms. These subscales include dry mouth, sticky saliva, senses (taste/smell), pain, and speech issues
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Sticky Saliva 6M
|
22.6 score on a scale
Standard Error 3.3
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Sticky Saliva 12M
|
20.0 score on a scale
Standard Error 3.2
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Sticky Saliva 24M
|
13.8 score on a scale
Standard Error 2.8
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Senses Baseline
|
6.2 score on a scale
Standard Error 1.8
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Senses 3M
|
21.9 score on a scale
Standard Error 3.0
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Dry Mouth Baseline
|
13.4 score on a scale
Standard Error 3.0
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Dry Mouth 3M
|
49.7 score on a scale
Standard Error 4.0
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Dry Mouth 6M
|
36.5 score on a scale
Standard Error 3.4
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Dry Mouth 12M
|
32.7 score on a scale
Standard Error 3.2
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Dry Mouth 24M
|
24.4 score on a scale
Standard Error 3.9
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Sticky Saliva Baseline
|
11.4 score on a scale
Standard Error 3.0
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Sticky Saliva 3M
|
35.8 score on a scale
Standard Error 4.1
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Senses 6M
|
14.8 score on a scale
Standard Error 2.4
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Senses 12M
|
13.7 score on a scale
Standard Error 2.4
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Senses 24M
|
9.3 score on a scale
Standard Error 2.1
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Pain Baseline
|
20.9 score on a scale
Standard Error 3.2
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Pain 3M
|
14.4 score on a scale
Standard Error 2.8
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Pain 6M
|
10.1 score on a scale
Standard Error 1.5
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Pain 12M
|
6.1 score on a scale
Standard Error 1.3
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Pain 24M
|
6.1 score on a scale
Standard Error 1.4
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Speech Baseline
|
15.0 score on a scale
Standard Error 2.7
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Speech 3M
|
10.7 score on a scale
Standard Error 2.3
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Speech 6M
|
6.1 score on a scale
Standard Error 1.6
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Speech 12M
|
6.5 score on a scale
Standard Error 1.7
|
|
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
HN35 Speech 24M
|
4.3 score on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 24 monthsQuestionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability.
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Composite MDADI 12M
|
89.1 score on a scale
Standard Error 1.6
|
|
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Composite MDADI 24M
|
92.6 score on a scale
Standard Error 1.3
|
|
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Composite MDADI Baseline
|
83.1 score on a scale
Standard Error 1.9
|
|
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Composite MDADI 6M
|
90.6 score on a scale
Standard Error 1.4
|
|
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Composite MDADI 3M
|
83.8 score on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: 2 yearsAccording to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria Higher grades indicate worse adverse events. This is assessed clinically by the patient's physician. Grade 1 is defined as "Faint erythema or dry desquamation" Grade 2 is defined as "Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema" Grade 3 is defined as "Moist Desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Skin Toxicity (Dermatitis)
Grade 1 dermatitis
|
90 percentage of patients with toxicity
|
|
Skin Toxicity (Dermatitis)
Grade 2 dermatitis
|
10 percentage of patients with toxicity
|
|
Skin Toxicity (Dermatitis)
Grade 3 dermatitis
|
0 percentage of patients with toxicity
|
SECONDARY outcome
Timeframe: from end of treatment to 2 years post treatmentNumber of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Gastrostomy Placement
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatmentAverage patient utilities (derived from EQ-5D) at baseline, 1, 3, 6, 12, 18, 24 and 36 months from the end of treatment. The overall health VAS is scored from 0 (worst imaginable health) to 100 (best imaginable health) based on the patient's self-reported health that day.
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
Baseline
|
75.97 score on a scale
Interval 3.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
1M
|
75.15 score on a scale
Interval 6.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
3M
|
78.75 score on a scale
Interval 6.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
6M
|
84.07 score on a scale
Interval 7.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
12M
|
83.83 score on a scale
Interval 8.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
18M
|
89.87 score on a scale
Interval 72.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
24M
|
87.0 score on a scale
Interval 33.0 to 100.0
|
|
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
36M
|
89.05 score on a scale
Interval 65.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death.
Outcome measures
| Measure |
INRT
n=67 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
2-year Overall and Progression-free Survival Following Treatment With INRT
Overall survival
|
91 percentage probability of 2-year OS/PFS
|
|
2-year Overall and Progression-free Survival Following Treatment With INRT
Progression-free survival
|
82 percentage probability of 2-year OS/PFS
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: disease-free patients who had their g-tubes removed
Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free
Outcome measures
| Measure |
INRT
n=9 Participants
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed
|
2.9 months from end of treatment
Interval 2.6 to 4.4
|
Adverse Events
INRT
Serious events: 12 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
INRT
n=67 participants at risk
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.0%
2/67 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Altered Mental Status
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Investigations
Blood Bilirubin Increased
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
2/67 • Number of events 4 • 3 years
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
3/67 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/67 • Number of events 2 • 3 years
|
|
Cardiac disorders
Heart Failure
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hypervolemia
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
3.0%
2/67 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
1.5%
1/67 • Number of events 2 • 3 years
|
|
General disorders
Localized Edema
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Trach Replacement
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Vascular disorders
Thromboembolic Event
|
1.5%
1/67 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
INRT
n=67 participants at risk
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Intensity modulated radiation therapy (IMRT): Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
83.6%
56/67 • Number of events 82 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.0%
4/67 • Number of events 4 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
70.1%
47/67 • Number of events 70 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
4/67 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
67.2%
45/67 • Number of events 79 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.0%
6/67 • Number of events 6 • 3 years
|
|
Ear and labyrinth disorders
Hearing loss
|
6.0%
4/67 • Number of events 4 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
17.9%
12/67 • Number of events 15 • 3 years
|
|
General disorders
Edema
|
11.9%
8/67 • Number of events 8 • 3 years
|
|
General disorders
Edema limbs
|
10.4%
7/67 • Number of events 8 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.9%
8/67 • Number of events 10 • 3 years
|
|
General disorders
Fatigue
|
64.2%
43/67 • Number of events 53 • 3 years
|
|
General disorders
Fever
|
9.0%
6/67 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.4%
11/67 • Number of events 11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.0%
4/67 • Number of events 5 • 3 years
|
|
Nervous system disorders
Headache
|
11.9%
8/67 • Number of events 11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
17.9%
12/67 • Number of events 14 • 3 years
|
|
Vascular disorders
Hypertension
|
62.7%
42/67 • Number of events 180 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.4%
7/67 • Number of events 7 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
4/67 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Vascular disorders
Hypotension
|
13.4%
9/67 • Number of events 11 • 3 years
|
|
Infections and infestations
Covid-19
|
9.0%
6/67 • Number of events 6 • 3 years
|
|
Psychiatric disorders
Insomnia
|
20.9%
14/67 • Number of events 16 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
20.9%
14/67 • Number of events 28 • 3 years
|
|
Infections and infestations
Mucosal infection
|
22.4%
15/67 • Number of events 17 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
64.2%
43/67 • Number of events 78 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.4%
7/67 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
70.1%
47/67 • Number of events 61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.4%
11/67 • Number of events 13 • 3 years
|
|
Gastrointestinal disorders
Odynophagia
|
46.3%
31/67 • Number of events 39 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
43.3%
29/67 • Number of events 45 • 3 years
|
|
General disorders
Pain
|
9.0%
6/67 • Number of events 6 • 3 years
|
|
Investigations
Platelet count decreased
|
17.9%
12/67 • Number of events 18 • 3 years
|
|
Endocrine disorders
Polydipsia
|
6.0%
4/67 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.9%
10/67 • Number of events 12 • 3 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
25.4%
17/67 • Number of events 21 • 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
10.4%
7/67 • Number of events 9 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.4%
11/67 • Number of events 19 • 3 years
|
|
Gastrointestinal disorders
Sore throat
|
58.2%
39/67 • Number of events 71 • 3 years
|
|
Gastrointestinal disorders
Thick secretions
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Infections and infestations
Thrush
|
13.4%
9/67 • Number of events 12 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
25.4%
17/67 • Number of events 24 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
14.9%
10/67 • Number of events 23 • 3 years
|
|
Investigations
WBC count decreased
|
13.4%
9/67 • Number of events 10 • 3 years
|
|
Investigations
Weight gain
|
6.0%
4/67 • Number of events 6 • 3 years
|
|
Investigations
Weight loss
|
40.3%
27/67 • Number of events 48 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
6/67 • Number of events 7 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.0%
4/67 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
20.9%
14/67 • Number of events 19 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
23.9%
16/67 • Number of events 17 • 3 years
|
|
Psychiatric disorders
Anxiety
|
13.4%
9/67 • Number of events 11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.5%
5/67 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
7/67 • Number of events 8 • 3 years
|
|
Vascular disorders
Lymphedema
|
23.9%
16/67 • Number of events 17 • 3 years
|
|
Eye disorders
Blurred vision
|
9.0%
6/67 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
55.2%
37/67 • Number of events 46 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.9%
20/67 • Number of events 28 • 3 years
|
|
Investigations
Creatinine increased
|
10.4%
7/67 • Number of events 7 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
20.9%
14/67 • Number of events 15 • 3 years
|
|
Psychiatric disorders
Depression
|
13.4%
9/67 • Number of events 10 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
77.6%
52/67 • Number of events 72 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.4%
15/67 • Number of events 21 • 3 years
|
|
Nervous system disorders
Dizziness
|
13.4%
9/67 • Number of events 9 • 3 years
|
|
Eye disorders
Dry eye
|
9.0%
6/67 • Number of events 6 • 3 years
|
Additional Information
David Sher, MD
University of Texas Southwestern Medical Center
Phone: (214)645-7607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place