Trial Outcomes & Findings for De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca (NCT NCT01530997)
NCT ID: NCT01530997
Last Updated: 2024-11-13
Results Overview
Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
Results posted on
2024-11-13
Participant Flow
Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC).
Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable.
Participant milestones
| Measure |
Single Intervention
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Intervention
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
Baseline characteristics by cohort
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
|
Marital Status
Married
|
34 Participants
n=5 Participants
|
|
Marital Status
Unmarried
|
10 Participants
n=5 Participants
|
|
Tobacco Use
Never Smoker
|
36 Participants
n=5 Participants
|
|
Tobacco Use
<=10 Pack Years
|
6 Participants
n=5 Participants
|
|
Tobacco Use
> 10 Pack Years
|
2 Participants
n=5 Participants
|
|
Primary Tumor Location
Tonsil
|
16 Participants
n=5 Participants
|
|
Primary Tumor Location
Base of Tongue
|
26 Participants
n=5 Participants
|
|
Primary Tumor Location
Unknown Primary
|
2 Participants
n=5 Participants
|
|
T Stage
T0
|
2 Participants
n=5 Participants
|
|
T Stage
T1
|
13 Participants
n=5 Participants
|
|
T Stage
T2
|
22 Participants
n=5 Participants
|
|
T Stage
T3
|
7 Participants
n=5 Participants
|
|
N Stage
N0
|
4 Participants
n=5 Participants
|
|
N Stage
N1
|
10 Participants
n=5 Participants
|
|
N Stage
N2a
|
2 Participants
n=5 Participants
|
|
N Stage
N2b
|
21 Participants
n=5 Participants
|
|
N Stage
N2c
|
7 Participants
n=5 Participants
|
|
HPV/p16 Status
HPV+/p16+
|
28 Participants
n=5 Participants
|
|
HPV/p16 Status
HPV-/p16+
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being openedPopulation: Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.
Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=43 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Median follow-up was 36 months with a range of 5-53 monthsLocal control is the arrest of cancer growth at the site of origin.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Two-Year Local Control
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Median follow-up was 36 months with a range of 5-53 monthsRegional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Regional Control
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: The median follow-up was 36 months with a range of 5-53 monthsCause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Cause-Specific Survival
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: the median follow-up was 36 months with a range ofDistant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Distant Metastases Free Survival
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Median follow-up was 36 months with a range of 5-53 months.The percentage of participants who are still alive from the start of treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
Overall Survival Rate
|
95 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRTThe head \& neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
n=42 Participants
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
n=42 Participants
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Feeding Tube
|
0 units on a scale
Interval 0.0 to 0.0
|
40 units on a scale
Interval 25.0 to 56.0
|
17 units on a scale
Interval 5.0 to 28.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Weight Loss
|
20 units on a scale
Interval 8.0 to 33.0
|
38 units on a scale
Interval 23.0 to 53.0
|
36 units on a scale
Interval 21.0 to 50.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Weight Gain
|
25 units on a scale
Interval 12.0 to 38.0
|
40 units on a scale
Interval 25.0 to 56.0
|
10 units on a scale
Interval 1.0 to 19.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Pain
|
19 units on a scale
Interval 14.0 to 25.0
|
25 units on a scale
Interval 18.0 to 32.0
|
26 units on a scale
Interval 20.0 to 33.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Swallowing
|
11 units on a scale
Interval 7.0 to 14.0
|
19 units on a scale
Interval 13.0 to 25.0
|
18 units on a scale
Interval 13.0 to 24.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Senses Problems
|
5 units on a scale
Interval 2.0 to 8.0
|
35 units on a scale
Interval 29.0 to 40.0
|
28 units on a scale
Interval 22.0 to 34.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Speech Problems
|
10 units on a scale
Interval 5.0 to 15.0
|
13 units on a scale
Interval 8.0 to 18.0
|
16 units on a scale
Interval 11.0 to 22.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Trouble with Social Eating
|
8 units on a scale
Interval 5.0 to 11.0
|
29 units on a scale
Interval 22.0 to 37.0
|
24 units on a scale
Interval 18.0 to 31.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Trouble with Social Contact
|
5 units on a scale
Interval 2.0 to 8.0
|
15 units on a scale
Interval 9.0 to 20.0
|
8 units on a scale
Interval 4.0 to 12.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Less Sexuality
|
13 units on a scale
Interval 7.0 to 19.0
|
34 units on a scale
Interval 24.0 to 45.0
|
23 units on a scale
Interval 15.0 to 31.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Teeth
|
3 units on a scale
Interval 0.0 to 6.0
|
10 units on a scale
Interval 5.0 to 16.0
|
12 units on a scale
Interval 6.0 to 18.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Opening Mouth
|
5 units on a scale
Interval 1.0 to 8.0
|
15 units on a scale
Interval 9.0 to 21.0
|
18 units on a scale
Interval 12.0 to 25.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Dry Mouth
|
16 units on a scale
Interval 10.0 to 22.0
|
69 units on a scale
Interval 61.0 to 77.0
|
64 units on a scale
Interval 56.0 to 72.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Sticky Saliva
|
6 units on a scale
Interval 2.0 to 10.0
|
61 units on a scale
Interval 51.0 to 72.0
|
49 units on a scale
Interval 41.0 to 58.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Cough
|
17 units on a scale
Interval 11.0 to 24.0
|
25 units on a scale
Interval 17.0 to 34.0
|
22 units on a scale
Interval 15.0 to 29.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Felt Ill
|
8 units on a scale
Interval 3.0 to 12.0
|
20 units on a scale
Interval 11.0 to 28.0
|
11 units on a scale
Interval 5.0 to 17.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Pain Killers
|
34 units on a scale
Interval 20.0 to 48.0
|
43 units on a scale
Interval 28.0 to 58.0
|
33 units on a scale
Interval 19.0 to 48.0
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Nutritional Supplements
|
39 units on a scale
Interval 24.0 to 53.0
|
55 units on a scale
Interval 40.0 to 70.0
|
40 units on a scale
Interval 25.0 to 56.0
|
SECONDARY outcome
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRTThe EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=44 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
n=42 Participants
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
n=42 Participants
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Financial difficulties
|
16 units on a scale
Interval 8.0 to 24.0
|
28 units on a scale
Interval 17.0 to 39.0
|
22 units on a scale
Interval 14.0 to 30.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Global health status/QoL
|
80 units on a scale
Interval 75.0 to 85.0
|
61 units on a scale
Interval 55.0 to 68.0
|
69 units on a scale
Interval 64.0 to 75.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Physical functioning
|
96 units on a scale
Interval 93.0 to 98.0
|
78 units on a scale
Interval 72.0 to 84.0
|
85 units on a scale
Interval 79.0 to 90.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Role functioning
|
96 units on a scale
Interval 93.0 to 98.0
|
65 units on a scale
Interval 57.0 to 74.0
|
77 units on a scale
Interval 69.0 to 84.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Emotional functioning
|
77 units on a scale
Interval 70.0 to 84.0
|
77 units on a scale
Interval 70.0 to 84.0
|
84 units on a scale
Interval 78.0 to 90.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Cognitive functioning
|
91 units on a scale
Interval 87.0 to 95.0
|
86 units on a scale
Interval 81.0 to 92.0
|
87 units on a scale
Interval 82.0 to 92.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Social functioning
|
88 units on a scale
Interval 83.0 to 93.0
|
66 units on a scale
Interval 58.0 to 74.0
|
81 units on a scale
Interval 75.0 to 87.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Fatigue
|
20 units on a scale
Interval 14.0 to 25.0
|
42 units on a scale
Interval 34.0 to 50.0
|
31 units on a scale
Interval 26.0 to 37.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Nausea and vomiting
|
2 units on a scale
Interval 0.0 to 3.0
|
13 units on a scale
Interval 8.0 to 17.0
|
4 units on a scale
Interval 1.0 to 6.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Pain
|
15 units on a scale
Interval 10.0 to 21.0
|
21 units on a scale
Interval 13.0 to 29.0
|
20 units on a scale
Interval 13.0 to 27.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Dyspnea
|
5 units on a scale
Interval 1.0 to 8.0
|
11 units on a scale
Interval 5.0 to 17.0
|
6 units on a scale
Interval 1.0 to 10.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Insomnia
|
23 units on a scale
Interval 16.0 to 30.0
|
34 units on a scale
Interval 25.0 to 43.0
|
23 units on a scale
Interval 15.0 to 31.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Appetite loss
|
14 units on a scale
Interval 8.0 to 19.0
|
40 units on a scale
Interval 30.0 to 49.0
|
33 units on a scale
Interval 24.0 to 42.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Constipation
|
12 units on a scale
Interval 5.0 to 18.0
|
17 units on a scale
Interval 10.0 to 23.0
|
16 units on a scale
Interval 9.0 to 23.0
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Diarrhea
|
5 units on a scale
Interval 1.0 to 8.0
|
4 units on a scale
Interval 1.0 to 7.0
|
6 units on a scale
Interval 2.0 to 10.0
|
SECONDARY outcome
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRTThe EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=43 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
n=41 Participants
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
n=42 Participants
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
The Eating Assessment Tool (EAT-10) Composite Score
|
4 units on a scale
Interval 2.0 to 5.0
|
13 units on a scale
Interval 9.0 to 16.0
|
11 units on a scale
Interval 8.0 to 14.0
|
SECONDARY outcome
Timeframe: Prior to CRT and 4-8 weeks after completion of CRTThe Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1\. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=37 Participants
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively.
|
6-8 Weeks Post-Treatment
n=31 Participants
This data was collected 6-8 weeks post-chemoradiotherapy.
|
Post-Surgery
This data was collected at the first follow-up post-surgery.
|
|---|---|---|---|
|
The Rosenbek Penetration Aspiration Scale
Thin Substances
|
1.30 units on a scale
Standard Deviation .62
|
1.90 units on a scale
Standard Deviation 1.83
|
—
|
|
The Rosenbek Penetration Aspiration Scale
Pureed Substances
|
1.03 units on a scale
Standard Deviation 0.16
|
1.19 units on a scale
Standard Deviation 0.54
|
—
|
|
The Rosenbek Penetration Aspiration Scale
Solid Substances
|
1.03 units on a scale
Standard Deviation 0.16
|
1.03 units on a scale
Standard Deviation 0.19
|
—
|
Adverse Events
Single Intervention
Serious events: 15 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Intervention
n=45 participants at risk
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.4%
2/45 • 4 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/45 • 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • 4 years
|
|
General disorders
Fever
|
2.2%
1/45 • 4 years
|
|
Vascular disorders
Hematoma
|
2.2%
1/45 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/45 • 4 years
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Soft tissue infection
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • 4 years
|
|
Nervous system disorders
Stroke
|
2.2%
1/45 • 4 years
|
Other adverse events
| Measure |
Single Intervention
n=45 participants at risk
Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
3/45 • 4 years
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • 4 years
|
|
Immune system disorders
Allergic reaction
|
2.2%
1/45 • 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
64.4%
29/45 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
3/45 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
68.9%
31/45 • 4 years
|
|
Psychiatric disorders
Anxiety
|
42.2%
19/45 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
5/45 • 4 years
|
|
Psychiatric disorders
Depression
|
31.1%
14/45 • 4 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
71.1%
32/45 • 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
71.1%
32/45 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
71.1%
32/45 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
71.1%
32/45 • 4 years
|
|
Gastrointestinal disorders
Esophageal pain
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.2%
1/45 • 4 years
|
|
General disorders
Fatigue
|
71.1%
32/45 • 4 years
|
|
General disorders
Fever
|
2.2%
1/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
15.6%
7/45 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/45 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
1/45 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
3/45 • 4 years
|
|
Endocrine disorders
Hypothyroidism
|
4.4%
2/45 • 4 years
|
|
General disorders
Infusion site extravasation
|
2.2%
1/45 • 4 years
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Mucosal infection
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
75.6%
34/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
62.2%
28/45 • 4 years
|
|
General disorders
Neck edema
|
64.4%
29/45 • 4 years
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/45 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
4.4%
2/45 • 4 years
|
|
General disorders
Pain
|
75.6%
34/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
68.9%
31/45 • 4 years
|
|
Investigations
Platelet count decreased
|
4.4%
2/45 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Salivary gland infection
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Soft tissue infection
|
4.4%
2/45 • 4 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
8.9%
4/45 • 4 years
|
|
Nervous system disorders
Syncope
|
4.4%
2/45 • 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
35.6%
16/45 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/45 • 4 years
|
|
Nervous system disorders
Vagus nerve disorder
|
2.2%
1/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
24.4%
11/45 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
18/45 • 4 years
|
|
Investigations
Weight loss
|
8.9%
4/45 • 4 years
|
|
Investigations
White blood cell decreased
|
2.2%
1/45 • 4 years
|
|
Investigations
Lymphopenia
|
2.2%
1/45 • 4 years
|
|
Gastrointestinal disorders
Diarrea
|
2.2%
1/45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.2%
1/45 • 4 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.2%
1/45 • 4 years
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60