Clinical Trials /

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

Description:

Investigators will determine whether treatment stratification by 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.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2015.126
  • SECONDARY ID: HUM00105447
  • NCT ID: NCT02784288

Conditions

  • Oropharyngeal Squamous Cell Cancer

Interventions

DrugSynonymsArms
CarboplatinRadiation and Chemotherapy
PaclitaxelRadiation and Chemotherapy

Purpose

Investigators will determine whether treatment stratification by 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.

Detailed Description

      Investigators will determine whether treatment stratification by 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 be stratified into one of three treatment

        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.
    

Trial Arms

NameTypeDescriptionInterventions
SurgeryExperimental
    RadiationExperimental
      Radiation and ChemotherapyExperimental
      • Carboplatin
      • Paclitaxel

      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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Difference in QOL (Quality of Life) measures 12 months post treatment when compared to historical controls
      Time Frame:12 Months
      Safety Issue:
      Description:QOL measures 12 months after completion of treatment will be compared to historical data using standard parametric methods such as linear and logistic regression modeling. 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).

      Secondary Outcome Measures

      Measure:Impact of neck dissection on shoulder function using the Neck Dissection Impairment Index
      Time Frame:2 Years
      Safety Issue:
      Description:The neck dissection impairment index will be scored and summarized for all patients who receive neck dissection. Between group comparisons for treatment groups and baseline characteristics (age at diagnosis, gender) will be performed using Analysis of Variance (ANOVA).
      Measure:Financial Toxicity
      Time Frame:2 years
      Safety Issue:
      Description:University of Michigan (UM) Financial and Work survey, scored per UM guidelines
      Measure:Financial Toxicity
      Time Frame:2 years
      Safety Issue:
      Description:COmprehensive Score for financial Toxicity (COST), scored according to Functional Assessment of Chronic Illness Therapy (FACIT) guidelines.
      Measure:The Number of Grade 3 or 4 Adverse Events Attributable to Any Treatment
      Time Frame:3 Years
      Safety Issue:
      Description:The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used to describe the maximum intensity of adverse events.
      Measure:Disease Specific Survival Time (DSS)
      Time Frame:3 Years
      Safety Issue:
      Description:Death from OPSCC (Oropharyngeal Squamous Cell Cancer) will be considered an event for disease specific survival (DSS) where death from other causes will be censored at time of death.
      Measure:Progression Free Survival Time (PFS)
      Time Frame:3 Years
      Safety Issue:
      Description:Progression free survival will be defined from date of completion of treatment to progression event.
      Measure:Overall Survival Time (OS)
      Time Frame:3 Years
      Safety Issue:
      Description:Death from any cause will be considered an event for overall survival.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Michigan Rogel Cancer Center

      Trial Keywords

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

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