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.
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
Drug | Synonyms | Arms |
---|
Carboplatin | | Radiation and Chemotherapy |
Paclitaxel | | Radiation 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
Name | Type | Description | Interventions |
---|
Surgery | Experimental | | |
Radiation | Experimental | | |
Radiation and Chemotherapy | Experimental | | |
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: | Active, not 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
Last Updated
June 30, 2021