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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:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With <span class="go-doc-concept go-doc-alteration">HPV+</span> Oropharyngeal Squamous Cell Cancer

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

    NCT ID: NCT02784288

    ORG ID: UMCC 2015.126

    NCI ID: HUM00105447

    Trial Conditions

    Oropharyngeal Squamous Cell Cancer

    Trial Interventions

    Drug Synonyms Arms
    Carboplatin Radiation and Chemotherapy
    Paclitaxel Radiation and Chemotherapy

    Trial 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

    Name Type Description Interventions
    Surgery Experimental
    Radiation Experimental
    Radiation and Chemotherapy Experimental 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.

    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 lactation

    - Women of child-bearing potential, defined as all women older than age 50 and
    anovulatory for 12 months, unless they are using highly effective methods of
    contraception during dosing and for 30 days after study treatment

    - 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

    - Other severe, acute, or chronic medical or psychiatric condition or laboratory
    abnormality that may increase the risk associated with study participation

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Difference in QOL (Quality of Life) measures 12 months post treatment when compared to historical controls

    Secondary Outcome Measures

    Progression Free Survival Time (PFS)

    Disease Specific Survival Time (DSS)

    Overall Survival Time (OS)

    The Number of Grade 3 or 4 Adverse Events Attributable to Any Treatment

    Trial Keywords

    head and neck neoplasms

    HPV

    human papilloma virus

    de-escalation

    low-risk

    oropharyngeal cancer