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 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2015.126HUM00105447
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oropharyngeal Squamous Cell Cancer

Keywords

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

Outcome Measures

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

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

Secondary Outcomes (5)

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

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

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

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

• Disease Specific Survival (DSS)

  3 Years

• Progression Free Survival (PFS)

  3 Years

• Overall Survival (OS)

  3 Years

Study Arms (1)

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

Interventions

Neck Dissection PROCEDURE

All patients will undergo neck dissection of the cervical lymph nodes

Neck Dissection

Standard-of-Care (SOC) Transoral Surgery of Primary Site PROCEDURE

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.

Neck Dissection

SOC Radiation RADIATION

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

Neck Dissection

SOC Carboplatin DRUG

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).

Neck Dissection

SOC Paclitaxel DRUG

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).

Neck Dissection

Videofluoroscopy PROCEDURE

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

Neck Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Interventions

Neck Dissection; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Paul Swiecicki
• Organization: University of Michigan

pswiecic@med.umich.edu

734-647-1017

Study Officials

• Paul Swiecicki, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 27, 2016
• Study Start: October 31, 2016
• Primary Completion: July 10, 2020
• Study Completion: July 12, 2022
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Locations

US (1)