Phase 2
N=34
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
Oropharyngeal Squamous Cell Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02784288 ↗Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Jun 2023
Primary outcome: Primary: Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment — -4.2; 0; 6.3; 10.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neck Dissection (Procedure); Standard-of-Care (SOC) Transoral Surgery of Primary Site (Procedure); SOC Radiation (Radiation); SOC Carboplatin (Drug); SOC Paclitaxel (Drug); Videofluoroscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment |
-4.2; 0; 6.3; 10.7; 0; 0 | — |
| SECONDARY Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index |
98 | — |
| SECONDARY Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment |
0.0; 0.0; 6.3; 10.7; -10; 0 | — |
| SECONDARY Disease Specific Survival (DSS) |
100 | — |
| SECONDARY Progression Free Survival (PFS) |
97 | — |
| SECONDARY Overall Survival (OS) |
100 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02784288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.