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

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• Neoplasms, Squamous Cell 134
• Carcinoma, Squamous Cell 1,778

Keywords

• head and neck neoplasms
• HPV
• human papilloma virus
• de-escalation
• low-risk
• oropharyngeal cancer

Study arms

• Experimental
  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.

  Procedure: Neck Dissection · Procedure: Standard-of-Care (SOC) Transoral Surgery of Primary Site · Radiation: SOC Radiation · Drug: SOC Carboplatin · Drug: SOC Paclitaxel · Procedure: Videofluoroscopy

Interventions

• ProcedureNeck Dissection

  All patients will undergo neck dissection of the cervical lymph nodes

• ProcedureStandard-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.

• RadiationSOC Radiation

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

• DrugSOC 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).

• DrugSOC 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).

• ProcedureVideofluoroscopy

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

Primary outcomes

1. 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

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

Secondary outcomes

1. 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

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

2. 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: 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

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

3. 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.

   Time frame: 3 Years

4. 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).

   Time frame: 3 Years

5. 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.

   Time frame: 3 Years

Baseline characteristics

Study documents

• Protocol, analysis plan and consent form · May 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided