Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Yeun-Chung Chang, M.D., Ph.D.

Significant evidence has shown that radiation therapy for patients with nasopharyngeal cancer (NPC) can cause swallowing abnormality. Based on our prior cross-sectional study for 184 NPC patients from 1995 to 1999, the findings of videofluoroscopic swallowing study (VFSS) revealed continuous deterioration of swallowing function of these patients even many years after radiation. We conducted a prospective study to evaluate the longitudinal change of swallowing function based on VFSS before, one month, one year and two years after completing radiation therapy. The amount of saliva was measured at the same time of VFSS study to test the relationship of decreased amount of saliva and swallowing function. Comparison of serial VFSS studies in NPC patients (n=84) and normal volunteers (n=38) were obtained. We assume that this study may reveal a complete understanding of changing swallowing patterns in the course of radiation therapy of patients with NPC. From this study, NPC patients can understand their own swallowing function. Therefore, the information may enable for earlier intervention of swallowing training or correction to avoid morbidity of radiation therapy in this patient group.

Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount

National Taiwan University Hospital

Yeun-Chung Chang

Infections

Behaviors and Mental Disorders

Carcinoma, Squamous Cell

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

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.

All patients will undergo neck dissection of the cervical lymph nodes

Neck Dissection

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.

Standard-of-Care (SOC) Transoral Surgery of 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.

SOC 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 (Radiation, Carboplatin and Paclitaxel).

SOC Carboplatin

SOC Paclitaxel

All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Videofluoroscopy

Paul Swiecicki, M.D.

Investigators will determine whether a treatment paradigm of up-front neck dissection, to more accurately pathologically stage patients, minimizing the number of treatment modalities in patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.

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:

1. 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.
2. Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
3. 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.

Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer

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

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

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:

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

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.

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).

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

University of Michigan Rogel Cancer Center

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

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.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Paul Swiecicki

HN-QOL: Eating

HN-QOL: Speech

HN-QOL: Pain

HN-QOL: Emotion

UW-QOL: Pain_general

UW-QOL: Pain_mouth

UW-QOL: Pain_throat

UW-QOL: Disfigurement

UW-QOL: Activity

UW-QOL: Recreation

UW-QOL: Employment

UW-QOL: Chewing

UW-QOL: Swallowing

UW-QOL: Saliva amount

UW-QOL: Saliva consistency

UW-QOL: Taste

UW-QOL: Speech

UW-QOL: Mucus amount

UW-QOL: Mucus consistency

V-RQOL: Physical

V-RQOL: Emotional

V-RQOL: Total

FACT H&N: Physical Well Being

FACT H&N: Social Well Being

FACT H&N: Emotional Well Being

FACT H&N: Functional Well Being

FACT H&N: HN subscale

FACT H&N: Total

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

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

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

HN-QOL- Eating

HN-QOL- Speech

HN-QOL- Pain

HN-QOL- Emotion

UWQOL-Pain_General

UWQOL- Pain_Mouth

UWQOL- Pain_throat

UWQOL- Disfigurement

UWQOL- activity

UWQOL-Recreation

UWQOL- Employment

UWQOL- Chewing

UWQOL- Swallowing

UWQOL- Saliva amount

UWQOL- Saliva consistency

UWQOL- Taste

UWQOL- Speech

UWQOL- Mucus amount

UWQOL- Mucus consistency

V-RQOL- Physical

V-RQOL- Emotional

V-RQOL- Total

FACT H&N- Physical well being

FACT H&N- Social well being

FACT H&N- Emotional well being

FACT H&N- Functional well being

FACT H&N- HN subscale

FACT H&N- total FACTHN

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.

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

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

Disease Specific Survival (DSS)

Progression Free Survival (PFS)

Overall Survival (OS)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount	NCT00173836	Nasopharyngeal ...		20 Years -	National Taiwan University Hospital
Swallowing Pattern of Patients With Nasopharyngeal Cancer Before and After Radiation Therapy: Longitudinal Study and Correction With Saliva Amount	NCT00173836	Nasopharyngeal ...		20 Years -	National Taiwan University Hospital
Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer	NCT02784288	Oropharyngeal S...	Neck Dissection Standard-of-Car... SOC Radiation SOC Carboplatin SOC Paclitaxel Videofluoroscop...	18 Years -	University of Michigan Rogel Cancer Center

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