Trial Outcomes & Findings for Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer (NCT NCT00068237)

Last Updated: 2019-02-05

Results Overview

Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

At the time of the submandibular salivary gland transfer

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Surgery + Transfer + Radiation Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Study STARTED	49
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgery + Transfer + Radiation Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Study Ineligible	3
Overall Study No protocol treatment received	2

Baseline Characteristics

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery + Transfer + Radiation n=44 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Age, Continuous	56.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of the submandibular salivary gland transfer

Population: Eligible patients who started study treatment.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=44 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"	34 participants

SECONDARY outcome

Timeframe: From start of treatment to 90 days

Population: Eligible patients who started RT

The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=43 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Percentage of Patients With Acute Xerostomia	25.6 percentage of participants Interval 12.5 to 38.6

SECONDARY outcome

Timeframe: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)

Population: Eligible patients with salivary scans submitted

Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=37 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Percentage of Patients With Normal Functioning Transferred Submandibular Gland Pre-surgery	70.3 percentage of participants Interval 55.5 to 85.0
Percentage of Patients With Normal Functioning Transferred Submandibular Gland Post-surgery	16.7 percentage of participants Interval 4.5 to 28.8
Percentage of Patients With Normal Functioning Transferred Submandibular Gland Post-radiotherapy	0.0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and one year

Population: Eligible patients with both baseline and 1-year questionnaire completed

The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=22 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire	13.6 score on a scale Interval 7.7 to 16.5

SECONDARY outcome

Timeframe: From surgery to 30 days after surgery

Population: Eligible patients who received the procedure

Facial edema was noted as present or absent following surgery.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=44 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Percentage of Patients Experiencing Facial Edema Following Surgery	13.6 percentage of participants Interval 3.5 to 23.8

SECONDARY outcome

Timeframe: From start of radiation therapy to 90 days

Population: Eligible patients who started RT

Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=43 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy	34.9 percentage of participants Interval 20.6 to 49.1

SECONDARY outcome

Timeframe: From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.

Population: Eligible patients who started RT and had toxicity data at least 90 days from the end of RT

Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Late" refers to toxicities occurring at least 91 days from the start of radiation therapy.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=38 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy	7.9 percentage of participants Interval 0.0 to 16.5

SECONDARY outcome

Timeframe: From registration to two years

Population: Eligible patients who started study treatment

Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=44 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Disease-free Survival Rate at 2 Years	71.7 percentage of participants Interval 58.2 to 85.3

SECONDARY outcome

Timeframe: From registration to two years

Population: Eligible patients who started study treatment

Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method.

Outcome measures

Outcome measures
Measure	Surgery + Transfer + Radiation n=44 Participants Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Survival Rate at 2 Years	76.4 percentage of participants Interval 63.6 to 89.2

Adverse Events

Surgery + Transfer + Radiation

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Surgery + Transfer + Radiation n=44 participants at risk Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Metabolism and nutrition disorders Anorexia	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Psychiatric disorders Confusion	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Apnoea	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Bleeding/hematoma	4.5% 2/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Cerebral embolism/CVA	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Wound infection	4.5% 2/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.

Other adverse events

Other adverse events
Measure	Surgery + Transfer + Radiation n=44 participants at risk Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Blood and lymphatic system disorders Hemoglobin decreased	9.3% 4/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Blood and lymphatic system disorders Lymphatics-Other	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Ear and labyrinth disorders Hearing impaired	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Ear and labyrinth disorders Hearing-Other	7.0% 3/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Endocrine disorders Hypothyroidism	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Constipation	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Diarrhea NOS	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Dry mouth	60.5% 26/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Dysphagia	14.0% 6/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Esophageal spasm	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Esophagitis NOS	14.0% 6/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders GI-other	7.0% 3/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Gastric ulcer	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Nausea	23.3% 10/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Radiation mucositis	32.6% 14/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Salivary gland disorder NOS	41.9% 18/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Stomatitis	7.0% 3/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Gastrointestinal disorders Vomiting NOS	16.3% 7/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Chest pain	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Fatigue	39.5% 17/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Infection NOS	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Esophagus	10.5% 4/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Joint	7.9% 3/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Larynx	15.8% 6/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Mucous Membrane	23.7% 9/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Other	26.3% 10/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Salivary Gland (xerostomia, taste impairme	57.9% 22/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Skin (within XRT field)	15.8% 6/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Late RT Toxicity: Subcutaneous Tissue (Within XRT field)	15.8% 6/38 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Pain due to radiation	25.6% 11/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Pain-other	18.6% 8/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Pyrexia	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
General disorders Rigors	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Immune system disorders Allergy-Other	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Infections and infestations Infection, Other	11.6% 5/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Injury, poisoning and procedural complications Dermatitis radiation NOS	27.9% 12/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Investigations Blood creatinine increased	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Investigations Leukopenia NOS	7.0% 3/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Investigations Weight decreased	27.9% 12/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Metabolism and nutrition disorders Anorexia	16.3% 7/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Metabolism and nutrition disorders Blood albumin decreased	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Metabolism and nutrition disorders Blood magnesium decreased	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Metabolism and nutrition disorders Dehydration	11.6% 5/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Metabolism and nutrition disorders Hypokalemia	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Musculoskeletal and connective tissue disorders Joint, muscle, or bone-Other	11.6% 5/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Nervous system disorders Depressed level of consciousness	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Nervous system disorders Peripheral motor neuropathy	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Nervous system disorders Peripheral sensory neuropathy	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Nervous system disorders Taste disturbance	53.5% 23/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Psychiatric disorders Anxiety NEC	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Psychiatric disorders Insomnia NEC	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Reproductive system and breast disorders Sexual/reproductive function-Other	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Cough	11.6% 5/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	11.6% 5/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Hemoptysis	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Respiratory, thoracic and mediastinal disorders Pulmonary-other	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	14.0% 6/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Skin and subcutaneous tissue disorders Erythema multiforme	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Skin and subcutaneous tissue disorders Skin discoloration	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Skin and subcutaneous tissue disorders Skin-Other	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Facial edema	13.6% 6/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Facial edema on the transfer si	13.6% 6/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Gland movement out of position	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Neck numbness	6.8% 3/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Neck numbness on the transfer s	4.5% 2/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Nerve injury: hypoglossal	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Nerve injury: hypoglossal on th	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Nerve injury: lingual	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Other	9.1% 4/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Shoulder weakness	4.5% 2/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Acute Surgical Complication: Shoulder weakness on the transf	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Late Surgical Complication: Other	22.7% 10/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Late Surgical Complication: Recurrent adenitis	2.3% 1/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Surgical and medical procedures Late Surgical Complication: Submental fullness	18.2% 8/44 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Vascular disorders Edema NOS	7.0% 3/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Vascular disorders Hemorrhage-Other	2.3% 1/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
Vascular disorders Lymphangiopathy NOS	4.7% 2/43 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place