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De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530997
Recruitment Status : Active, not recruiting
First Posted : February 10, 2012
Results First Posted : August 9, 2017
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Interventions Radiation: Intensity Modulated Radiotherapy (IMRT)
Drug: Cisplatin
Procedure: Limited surgical evaluation
Enrollment 45
Recruitment Details Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC).
Pre-assignment Details 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.
Arm/Group Title Single Intervention
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 45
Completed 43
Not Completed 2
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             1
Arm/Group Title De-escalated Radiation and Chemotherapy
Hide Arm/Group Description

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 Number of Baseline Participants 44
Hide Baseline Analysis Population Description
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 leaving 44 patients included in the baseline characteristics.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
61
(44 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
39
  88.6%
Male
5
  11.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   9.1%
White
40
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Married
34
  77.3%
Unmarried
10
  22.7%
Tobacco Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Never Smoker
36
  81.8%
<=10 Pack Years
6
  13.6%
> 10 Pack Years
2
   4.5%
Primary Tumor Location  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Tonsil
16
  36.4%
Base of Tongue
26
  59.1%
Unknown Primary
2
   4.5%
T Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
T0
2
   4.5%
T1
13
  29.5%
T2
22
  50.0%
T3
7
  15.9%
[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer.
N Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
N0
4
   9.1%
N1
10
  22.7%
N2a
2
   4.5%
N2b
21
  47.7%
N2c
7
  15.9%
[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer.
HPV/p16 Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
HPV+/p16+
28
  63.6%
HPV-/p16+
16
  36.4%
[1]
Measure Description: Human papilloma virus (HPV) is a common virus that can cause cancer. p16 is a tumor suppression gene that acts as a cyclin-dependent kinase inhibitor. HPV-related cancers with p16 overexpression (p16+) have a better prognosis than those not related to HPV due to an increased sensitivity to radiotherapy.
1.Primary Outcome
Title Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
Hide Description Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
Time Frame 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
Hide Outcome Measure Data
Hide Analysis Population Description
Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.
Arm/Group Title De-escalated Radiation and Chemotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
37
  86.0%
2.Secondary Outcome
Title Two-Year Local Control
Hide Description Local control is the arrest of cancer growth at the site of origin.
Time Frame Median follow-up was 36 months with a range of 5-53 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title De-escalated Radiation and Chemotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Regional Control
Hide Description Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.
Time Frame Median follow-up was 36 months with a range of 5-53 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Intervention
Hide Arm/Group Description:

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 Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title Cause-Specific Survival
Hide Description Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.
Time Frame The median follow-up was 36 months with a range of 5-53 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Intervention
Hide Arm/Group Description:

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 Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
100
5.Secondary Outcome
Title Distant Metastases Free Survival
Hide Description Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.
Time Frame the median follow-up was 36 months with a range of
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Intervention
Hide Arm/Group Description:

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 Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
100
6.Secondary Outcome
Title Overall Survival Rate
Hide Description The percentage of participants who are still alive from the start of treatment.
Time Frame Median follow-up was 36 months with a range of 5-53 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Intervention
Hide Arm/Group Description:

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 Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
95
7.Secondary Outcome
Title European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
Hide Description

The 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).

Time Frame Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline 6-8 Weeks Post-Treatment Post-Surgery
Hide Arm/Group Description:
This data was collected pre-chemoradiotherapy treatment.
This data was collected 6-8 weeks post-chemoradiotherapy.
This data was collected at the first follow-up post-surgery.
Overall Number of Participants Analyzed 44 42 42
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Pain
19
(14 to 25)
25
(18 to 32)
26
(20 to 33)
Swallowing
11
(7 to 14)
19
(13 to 25)
18
(13 to 24)
Senses Problems
5
(2 to 8)
35
(29 to 40)
28
(22 to 34)
Speech Problems
10
(5 to 15)
13
(8 to 18)
16
(11 to 22)
Trouble with Social Eating
8
(5 to 11)
29
(22 to 37)
24
(18 to 31)
Trouble with Social Contact
5
(2 to 8)
15
(9 to 20)
8
(4 to 12)
Less Sexuality
13
(7 to 19)
34
(24 to 45)
23
(15 to 31)
Teeth
3
(0 to 6)
10
(5 to 16)
12
(6 to 18)
Opening Mouth
5
(1 to 8)
15
(9 to 21)
18
(12 to 25)
Dry Mouth
16
(10 to 22)
69
(61 to 77)
64
(56 to 72)
Sticky Saliva
6
(2 to 10)
61
(51 to 72)
49
(41 to 58)
Cough
17
(11 to 24)
25
(17 to 34)
22
(15 to 29)
Felt Ill
8
(3 to 12)
20
(11 to 28)
11
(5 to 17)
Pain Killers
34
(20 to 48)
43
(28 to 58)
33
(19 to 48)
Nutritional Supplements
39
(24 to 53)
55
(40 to 70)
40
(25 to 56)
Feeding Tube
0
(0 to 0)
40
(25 to 56)
17
(5 to 28)
Weight Loss
20
(8 to 33)
38
(23 to 53)
36
(21 to 50)
Weight Gain
25
(12 to 38)
40
(25 to 56)
10
(1 to 19)
8.Secondary Outcome
Title European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
Hide Description The 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.
Time Frame Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline 6-8 Weeks Post-Treatment Post-Surgery
Hide Arm/Group Description:
This data was collected pre-chemoradiotherapy treatment.
This data was collected 6-8 weeks post-chemoradiotherapy.
This data was collected at the first follow-up post-surgery.
Overall Number of Participants Analyzed 44 42 42
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Global health status/QoL
80
(75 to 85)
61
(55 to 68)
69
(64 to 75)
Physical functioning
96
(93 to 98)
78
(72 to 84)
85
(79 to 90)
Role functioning
96
(93 to 98)
65
(57 to 74)
77
(69 to 84)
Emotional functioning
77
(70 to 84)
77
(70 to 84)
84
(78 to 90)
Cognitive functioning
91
(87 to 95)
86
(81 to 92)
87
(82 to 92)
Social functioning
88
(83 to 93)
66
(58 to 74)
81
(75 to 87)
Fatigue
20
(14 to 25)
42
(34 to 50)
31
(26 to 37)
Nausea and vomiting
2
(0 to 3)
13
(8 to 17)
4
(1 to 6)
Pain
15
(10 to 21)
21
(13 to 29)
20
(13 to 27)
Dyspnea
5
(1 to 8)
11
(5 to 17)
6
(1 to 10)
Insomnia
23
(16 to 30)
34
(25 to 43)
23
(15 to 31)
Appetite loss
14
(8 to 19)
40
(30 to 49)
33
(24 to 42)
Constipation
12
(5 to 18)
17
(10 to 23)
16
(9 to 23)
Diarrhea
5
(1 to 8)
4
(1 to 7)
6
(2 to 10)
Financial difficulties
16
(8 to 24)
28
(17 to 39)
22
(14 to 30)
9.Secondary Outcome
Title The Eating Assessment Tool (EAT-10) Composite Score
Hide Description The 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.
Time Frame Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline 6-8 Weeks Post-Treatment Post-Surgery
Hide Arm/Group Description:
This data was collected pre-chemoradiotherapy treatment.
This data was collected 6-8 weeks post-chemoradiotherapy.
This data was collected at the first follow-up post surgery.
Overall Number of Participants Analyzed 43 41 42
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4
(2 to 5)
13
(9 to 16)
11
(8 to 14)
10.Secondary Outcome
Title The Rosenbek Penetration Aspiration Scale
Hide Description

The 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.

Time Frame Prior to CRT and 4-8 weeks after completion of CRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-treatment Post-treatment
Hide Arm/Group Description:
This data was collected before the treatment.
This data was collected 4-8 weeks after chemoradiation therapy
Overall Number of Participants Analyzed 37 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Thin Substances 1.30  (.62) 1.90  (1.83)
Pureed Substances 1.03  (0.16) 1.19  (0.54)
Solid Substances 1.03  (0.16) 1.03  (0.19)
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Intervention
Hide Arm/Group Description

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

All-Cause Mortality
Single Intervention
Affected / at Risk (%)
Total   1/45 (2.22%) 
Hide Serious Adverse Events
Single Intervention
Affected / at Risk (%)
Total   15/45 (33.33%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders - Other, specify * 1 [1]  1/45 (2.22%) 
Blood and lymphatic system disorders - Other, specify * 1 [2]  1/45 (2.22%) 
Febrile neutropenia * 1  1/45 (2.22%) 
Gastrointestinal disorders   
Constipation * 1  1/45 (2.22%) 
Diarrhea * 1  1/45 (2.22%) 
Nausea * 1  1/45 (2.22%) 
Vomiting * 1  2/45 (4.44%) 
General disorders   
Fever * 1  1/45 (2.22%) 
Infections and infestations   
Sepsis * 1  1/45 (2.22%) 
Urinary tract infection * 1  1/45 (2.22%) 
Soft tissue infection * 1  1/45 (2.22%) 
Investigations   
Alanine aminotransferase increased * 1  1/45 (2.22%) 
Aspartate aminotransferase increased * 1  1/45 (2.22%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/45 (4.44%) 
Hyponatremia * 1  1/45 (2.22%) 
Anorexia * 1  1/45 (2.22%) 
Nervous system disorders   
Stroke * 1  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  2/45 (4.44%) 
Vascular disorders   
Hematoma * 1  1/45 (2.22%) 
Hypotension * 1  1/45 (2.22%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Pulmonary embolus/Blood clot
[2]
Bleeding
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Intervention
Affected / at Risk (%)
Total   40/45 (88.89%) 
Blood and lymphatic system disorders   
Anemia * 1  3/45 (6.67%) 
Ear and labyrinth disorders   
Middle ear inflammation * 1  1/45 (2.22%) 
Tinnitus * 1  16/45 (35.56%) 
Endocrine disorders   
Hypothyroidism * 1  2/45 (4.44%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/45 (2.22%) 
Constipation * 1  2/45 (4.44%) 
Dry mouth * 1  32/45 (71.11%) 
Dysphagia * 1  32/45 (71.11%) 
Esophageal pain * 1  1/45 (2.22%) 
Esophageal stenosis * 1  1/45 (2.22%) 
Mucositis oral * 1  34/45 (75.56%) 
Nausea * 1  28/45 (62.22%) 
Vomiting * 1  18/45 (40.00%) 
Diarrea * 1  1/45 (2.22%) 
General disorders   
Fatigue * 1  32/45 (71.11%) 
Fever * 1  1/45 (2.22%) 
Infusion site extravasation * 1  1/45 (2.22%) 
Neck edema * 1  29/45 (64.44%) 
Pain * 1  34/45 (75.56%) 
Immune system disorders   
Allergic reaction * 1  1/45 (2.22%) 
Infections and infestations   
Mucosal infection * 1  1/45 (2.22%) 
Salivary gland infection * 1  1/45 (2.22%) 
Sinusitis * 1  1/45 (2.22%) 
Soft tissue infection * 1  2/45 (4.44%) 
Upper respiratory infection * 1  1/45 (2.22%) 
Infections and infestations - Other, specify * 1 [1]  1/45 (2.22%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  32/45 (71.11%) 
Investigations   
Alanine aminotransferase increased * 1  1/45 (2.22%) 
Neutrophil count decreased * 1  1/45 (2.22%) 
Platelet count decreased * 1  2/45 (4.44%) 
Weight loss * 1  4/45 (8.89%) 
White blood cell decreased * 1  1/45 (2.22%) 
Lymphopenia * 1  1/45 (2.22%) 
Metabolism and nutrition disorders   
Anorexia * 1  31/45 (68.89%) 
Dehydration * 1  5/45 (11.11%) 
Hyperglycemia * 1  1/45 (2.22%) 
Hypoalbuminemia * 1  1/45 (2.22%) 
Hyponatremia * 1  3/45 (6.67%) 
Musculoskeletal and connective tissue disorders   
Osteonecrosis of jaw * 1  2/45 (4.44%) 
Trismus * 1  1/45 (2.22%) 
Nervous system disorders   
Dysgeusia * 1  32/45 (71.11%) 
Syncope * 1  2/45 (4.44%) 
Vagus nerve disorder * 1  1/45 (2.22%) 
Psychiatric disorders   
Anxiety * 1  19/45 (42.22%) 
Depression * 1  14/45 (31.11%) 
Renal and urinary disorders   
Acute kidney injury * 1  3/45 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Hoarseness * 1  7/45 (15.56%) 
Nasal congestion * 1  1/45 (2.22%) 
Pharyngeal mucositis * 1  31/45 (68.89%) 
Voice alteration * 1  11/45 (24.44%) 
Respiratory, thoracic and mediastinal disorders - Other, specify * 1 [2]  1/45 (2.22%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  29/45 (64.44%) 
Rash acneiform * 1  1/45 (2.22%) 
Surgical and medical procedures   
Surgical and medical procedures - Other, specify * 1  4/45 (8.89%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Respiratory Infection
[2]
Severely altered eating/swallowing
Per the protocol, affiliate sites will only report grade 3/4 and all fatal (grade 5) toxicities. 1/2 toxicities were not reported for affiliate sites.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01530997    
Other Study ID Numbers: LCCC 1120
First Submitted: January 20, 2012
First Posted: February 10, 2012
Results First Submitted: March 30, 2017
Results First Posted: August 9, 2017
Last Update Posted: March 9, 2020