Oropharyngeal Squamous Cell CancerPhase 2NCT02784288
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
A Phase 2 study testing Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site and SOC Radiation in people with Oropharyngeal Squamous Cell Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Cancer
- What is being tested?
- Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site and SOC Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2016to 12 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
After enrollment, all patients will undergo neck dissection and primary site biopsy. Pathology will be reviewed, and patients will proceed into one of three standard-of-care (SOC) treatment groups. The treatments themselves are not the focus of this study; the focus of this study is quality of life in this population, after a pathology-based treatment plan, to assess the utility of the investigational "neck dissection first" paradigm. The SOC treatment plans are as follows:
- 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.
- Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
- 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.
This study was initially registered as if it were an inter-group comparison; however, the original and consistent intent has been to determine whether a treatment paradigm of neck dissection guided staging as a whole can minimize the number of standard treatment methods used, leading to improved quality of life in low risk patients with HPV+ oropharyngeal squamous cell cancer. Though certain groups are expected to need multimodal definitive treatment downstream of the experimental "neck dissection first" paradigm, the population must be assessed as one group in this trial to assess the utility of the paradigm.
- Conditions
- Oropharyngeal Squamous Cell Cancer
- Being tested
- Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site, SOC Radiation, SOC Carboplatin, SOC Paclitaxel
- Keywords
- head and neck neoplasms, HPV, human papilloma virus, de-escalation, low-risk, oropharyngeal cancer
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck DissectionProcedure or surgery
All patients will undergo neck dissection of the cervical lymph nodes
Standard-of-Care (SOC) Transoral Surgery of Primary SiteProcedure or surgery
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.
SOC RadiationRadiation
Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
SOC CarboplatinDrug
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).
SOC PaclitaxelDrug
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).
VideofluoroscopyProcedure or surgery
All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Neck Dissection; Procedure: Standard-of-Care (SOC) Transoral Surgery of Primary Site; Radiation: SOC Radiation; Drug: SOC Carboplatin; Drug: SOC Paclitaxel; Procedure: Videofluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 2 years post-treatment (up to approximately 27 months post neck dissection)
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.
Measured: 3 Years
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).
Measured: 3 Years
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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start31 Oct 2016
- Primary completion10 Jul 2020
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharyngeal Squamous Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Swiecicki, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784288
- Sponsor's protocol ID
- UMCC 2015.126
- Other IDs
- HUM00105447
- Status last verified
- Jun 2023
- First submitted
- 24 May 2016
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02784288
- Acronym / sponsor ID
- UMCC 2015.126
- Conditions
- Oropharyngeal Squamous Cell Cancer
- Keywords
- head and neck neoplasms, HPV, human papilloma virus, de-escalation, low-risk, oropharyngeal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After enrollment, all patients will undergo neck dissection and primary site biopsy. Pathology will be reviewed, and patients will proceed into one of three standard-of-care (SOC) treatment groups. The treatments themselves are not the focus of this study; the focus of this study is quality of life in this population, after a pathology-based treatment plan, to assess the utility of the investigational "neck dissection first" paradigm. The SOC treatment plans are as follows:
- 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.
- Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
- 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.
This study was initially registered as if it were an inter-group comparison; however, the original and consistent intent has been to determine whether a treatment paradigm of neck dissection guided staging as a whole can minimize the number of standard treatment methods used, leading to improved quality of life in low risk patients with HPV+ oropharyngeal squamous cell cancer. Though certain groups are expected to need multimodal definitive treatment downstream of the experimental "neck dissection first" paradigm, the population must be assessed as one group in this trial to assess the utility of the paradigm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck Dissection | Experimental | Procedure: Neck Dissection, Procedure: Standard-of-Care (SOC) Transoral Surgery of Primary Site, Radiation: SOC Radiation, Drug: SOC Carboplatin, Drug: SOC Paclitaxel, Procedure: VideofluoroscopyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck DissectionAll patients will undergo neck dissection of the cervical lymph nodes | Procedure or surgery | Neck Dissection |
| Standard-of-Care (SOC) Transoral Surgery of Primary SitePatients 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. | Procedure or surgery | Neck Dissection |
| SOC RadiationPatients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. | Radiation | Neck Dissection |
| SOC CarboplatinPatients 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). | Drug | Neck Dissection |
| SOC PaclitaxelPatients 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). | Drug | Neck Dissection |
| VideofluoroscopyAll patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function. | Procedure or surgery | Neck Dissection |
Primary outcome
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment
Time frame: Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).
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
5 secondary outcomes
Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index
Time frame: 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
Time frame: 2 years post-treatment (up to approximately 27 months post neck dissection)
Disease Specific Survival (DSS)
Time frame: 3 Years
Progression Free Survival (PFS)
Time frame: 3 Years
Overall Survival (OS)
Time frame: 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Swiecicki, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site and SOC Radiation in people with Oropharyngeal Squamous Cell Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment (time frame: Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.