Phase II Treatment Stratification Trial Using Neck Dissec... | NCT02784288

NCT02784288

ID	Type	Description	Link
HUM00105447	Other Identifier	University of Michigan

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

After enrollment, all patients will undergo neck dissection and primary site biopsy. Pathology will be reviewed, and patients will proceed into one of three standard-of-care (SOC) treatment groups. The treatments themselves are not the focus of this study; the focus of this study is quality of life in this population, after a pathology-based treatment plan, to assess the utility of the investigational "neck dissection first" paradigm. The SOC treatment plans are as follows:

Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site.
Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation.

After completion of therapy (surgical, radiation, or combined modality) patients will be followed closely on an outpatient basis including regular exams, quality of life questionnaires, and interval surveillance imaging as clinically indicated. Swallowing function will also be addressed by videofluoroscopy one year after completion of therapy. Blood/plasma and oral rinses for correlative studies will be collected at 3-month intervals during 3 years of follow up.

This study was initially registered as if it were an inter-group comparison; however, the original and consistent intent has been to determine whether a treatment paradigm of neck dissection guided staging as a whole can minimize the number of standard treatment methods used, leading to improved quality of life in low risk patients with HPV+ oropharyngeal squamous cell cancer. Though certain groups are expected to need multimodal definitive treatment downstream of the experimental "neck dissection first" paradigm, the population must be assessed as one group in this trial to assess the utility of the paradigm.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neck Dissection	Experimental	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation.	Procedure: Neck Dissection Procedure: Standard-of-Care (SOC) Transoral Surgery of Primary Site Radiation: SOC Radiation Drug: SOC Carboplatin Drug: SOC Paclitaxel Procedure: Videofluoroscopy

Name	Type	Description	Arm Group Labels	Other Names
Neck Dissection	Procedure	All patients will undergo neck dissection of the cervical lymph nodes	Neck Dissection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment	Four QOL instruments will be administered: the University of Washington Quality of Life (UWQOL), University of Michigan Head and Neck Quality of Life Instrument (HN-QOL), the University of Michigan Voice Related Quality of Life Measure (V-RQOL), and the FACT Head and Neck (version 4) (FACT H&N). Results of each of the 4 surveys will be reported in separate rows in the results table. The difference in scores from baseline to 12 months after completion of study treatment is calculated for each participant, with the median across all participants reported for each survey. Higher scores indicate better QOLs. Range for Questionnaires: HN QOLs: -100 to +100 VR QOLs: -100 to +100 UW QOLs: -100 to +100 FACTHN Physical: -28 to +28 FACTHN Social: -28 to +28 FACTHN Emotional: -24 to +24 FACTHN Functional: -28 to +28 FACTHN subscale: -40 to +40 FACTHN Total: -148 to +148	Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).

Secondary Outcomes

Measure	Description	Time Frame
Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index	The neck dissection impairment index will be scored and summarized for all patients who receive neck dissection. Scores ranging from 0-100 with higher scores indicating better function	2 years post-treatment (up to approximately 27 months post neck dissection)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have pathologically-confirmed, previously untreated, p16-positive oropharyngeal squamous cell carcinoma
Patients must have pretreatment neck and chest imaging
Tumors must be potentially surgically resectable via a transoral approach, at the discretion of the treating surgeon
Patients with T stage T1-3
Patients with N stage N0-N2c
ECOG (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) Performance status 0-2
Patients are adults (Age >18)
Patients must agree to biospecimen submission for tissue and serum processing and storage for secondary biomarker studies
Patients must give documented informed consent to participate in this study.
Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of chemoradiation (treatment) and for 3 months after discontinuing treatment. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to starting treatment.
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 30 days after study treatment. Women not of childbearing potential will be defined as all women older than age 50 and anovulatory for 12 months.
Sexually active males must use a condom during intercourse while receiving chemoradiation and for 90 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Likewise, male subjects should not donate sperm during the time they are receiving chemoradiation and for 90 days after stopping treatment.

Exclusion Criteria:

Prior head and neck radiation or prior chemotherapy for HNSCC (Head and Neck Squamous Cell Carcinoma)
Patients with T4 disease
Patients with N3 disease
FNA evidence of squamous cell carcinoma involving 3 or more lymph nodes
Patients with matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread
Patients with an outside primary site biopsy showing perineural or perivascular invasion
Documented evidence of distant metastases.
Active infection
Patients residing in prison.
Age < 18 years
Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Unstable angina or a history of myocardial ischemia within prior 6 months
Patients with any of the following laboratory values at baseline:
- Absolute neutrophil count (ANC) < 1,000/mm3
- Platelets < 75,000/mm3
- Hemoglobin < 9.0 gm/dL
- Calculated or measured creatinine clearance (method determined by the prescribing physicians) < 50 ml/min
- Bilirubin > 1.5 x ULN (Upper Limit of Normal), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
- Aspartate transaminase (AST) > 3.0 x ULN
- Alanine transaminase (ALT) > 3.0 x ULN
Pregnancy or breastfeeding female.
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Contacts/Locations Module

Name	Affiliation	Role
Paul Swiecicki, M.D.	University of Michigan Rogel Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Cancer Center		Ann Arbor	Michigan	48109	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	May 3, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Units	Counts
Participants	BG00034

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00060(40 to 76)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006
Male	BG00028

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG00033

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00034

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment

Four QOL instruments will be administered: the University of Washington Quality of Life (UWQOL), University of Michigan Head and Neck Quality of Life Instrument (HN-QOL), the University of Michigan Voice Related Quality of Life Measure (V-RQOL), and the FACT Head and Neck (version 4) (FACT H&N). Results of each of the 4 surveys will be reported in separate rows in the results table. The difference in scores from baseline to 12 months after completion of study treatment is calculated for each participant, with the median across all participants reported for each survey. Higher scores indicate better QOLs.

Range for Questionnaires:

HN QOLs: -100 to +100 VR QOLs: -100 to +100 UW QOLs: -100 to +100 FACTHN Physical: -28 to +28 FACTHN Social: -28 to +28 FACTHN Emotional: -24 to +24 FACTHN Functional: -28 to +28 FACTHN subscale: -40 to +40 FACTHN Total: -148 to +148

only 19 patients, out of 34, were compliant in completing the 12 month QOLs.

Posted

Median

Full Range

score on a scale

Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).

ID	Title	Description
OG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Units	Counts
Participants	OG00019

Title

Denominators

Categories

HN-QOL: Eating

- ParticipantsOG00019

Title	Measurements
	OG000-4.2(-37.5 to 29.2)

HN-QOL: Speech

- ParticipantsOG000

Secondary

Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index

The neck dissection impairment index will be scored and summarized for all patients who receive neck dissection.

Scores ranging from 0-100 with higher scores indicating better function

Posted

Median

Full Range

score on a scale

2 years post-treatment (up to approximately 27 months post neck dissection)

ID	Title	Description
OG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Secondary

Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment

Four QOL instruments will be administered: the University of Washington Quality of Life (UWQOL), University of Michigan Head and Neck Quality of Life Instrument (HN-QOL), the University of Michigan Voice Related Quality of Life Measure (V-RQOL), and the FACT Head and Neck (version 4) (FACT H&N). Results of each of the 4 surveys will be reported in separate rows in the results table. The difference in scores from baseline to 24 months after completion of study treatment is calculated for each participant, with the median across all participants reported for each survey. Higher scores indicate better QOLs.

Range for Questionnaires:

only 19 patients, out of 34, were compliant in completing the 24 month QOLs

Posted

Median

Full Range

score on a scale

2 years post-treatment (up to approximately 27 months post neck dissection)

ID	Title	Description
OG000	Neck Dissection	Patients underwent up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Secondary

Disease Specific Survival (DSS)

Proportion of patients alive at 3 years from date of neck dissection. Death from OPSCC (Oropharyngeal Squamous Cell Cancer) will be considered an event for DSS. Death from other causes will be censored at time of death.

Posted

Number

percentage of participants

3 Years

ID	Title	Description
OG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Secondary

Progression Free Survival (PFS)

Proportion of patients alive and free of disease persistence, progression or recurrence at 3 years from the date of completion of study treatment. Persistent disease at completion of treatment, post-treatment recurrence or disease specific death will be defined events for progression free survival (PFS).

Posted

Number

95% Confidence Interval

percentage of participants

3 Years

ID	Title	Description
OG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Secondary

Overall Survival (OS)

Proportion of patients alive at 3 years from date of neck dissection. Death from any cause will be considered an event for overall survival.

Posted

Number

Percent of Patients

3 Years

ID	Title	Description
OG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Neck Dissection	Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation: Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes SOC Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function. All patients, regardless of intervention were combined into one arm for analysis	0	34	3	34	33	34

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 events1 affected34 at risk
Oral Hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0002 events2 affected34 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Anemia	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events6 affected34 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0005 events4 affected34 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Avascular necrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Back Pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Cardiac disorders- Other	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
chest wall pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00016 events14 affected34 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 events6 affected34 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected34 at risk
Dermatitis radiation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00015 events11 affected34 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00035 events20 affected34 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00034 events19 affected34 at risk
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00029 events17 affected34 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Ear and labyrinth disorders - Other	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Ear pain	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events5 affected34 at risk
Edema face	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Esophageal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events6 affected34 at risk
Esophageal ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Facial muscle weakness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Facial pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG00022 events14 affected34 at risk
Flank pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Gastrointestinal disorders - Other	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
General disorders and administration site conditions- Other	General disorders	CTCAE (4.0)	Systematic Assessment	EG00018 events10 affected34 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events4 affected34 at risk
Hearing impaired	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events6 affected34 at risk
Hot flashes	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Hyperglycemia	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events6 affected34 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected34 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Hypothyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Infections and infestations - Other	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 events4 affected34 at risk
Injury, poisoning and procedural complications - Other	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected34 at risk
Joint range of motion decreased lumbar spine	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Localized edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Lymphedema	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events6 affected34 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0007 events3 affected34 at risk
Meningismus	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Metabolism and nutrition disorders - Other	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Mucosal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00020 events13 affected34 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Muscle weakness trunk	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Musculoskeletal and connective tissue disorder - Other	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 events5 affected34 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events6 affected34 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00019 events15 affected34 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00011 events9 affected34 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Oral dysesthesia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00021 events14 affected34 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG00030 events14 affected34 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Palpitations	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Papulopustular rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Personality change	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Postoperative hemorrhage	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events2 affected34 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Renal and urinary disorders - Other	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Seroma	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected34 at risk
Skin infection	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00012 events10 affected34 at risk
Spinal fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Surgical and medical procedures - Other	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events2 affected34 at risk
Testicular disorder	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Trismus	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events6 affected34 at risk
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected34 at risk
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Vertigo	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected34 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events7 affected34 at risk
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG00014 events14 affected34 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected34 at risk

ID	Term
D006258	Head and Neck Neoplasms
D009959	Oropharyngeal Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D037981	Neck Dissection
D059039	Standard of Care

Ancestor Terms

ID	Term
D008197	Lymph Node Excision
D013514	Surgical Procedures, Operative
D013517	Otorhinolaryngologic Surgical Procedures
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation