Clinical trial NCT02784288
Conditions: Oropharyngeal Squamous Cell Cancer
Keywords: head and neck neoplasms HPV human papilloma virus de-escalation low-risk oropharyngeal cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2016-10-31; Completion date: 2022-07-12
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

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:

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.

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.

Arms: arm 1: 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.
Interventions: intervention 1: Neck Dissection intervention 2: Standard-of-Care (SOC) Transoral Surgery of Primary Site intervention 3: SOC Radiation intervention 4: SOC Carboplatin intervention 5: SOC Paclitaxel intervention 6: Videofluoroscopy
Intervention descriptions: intervention 1: All patients will undergo neck dissection of the cervical lymph nodes intervention 2: 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. intervention 3: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. intervention 4: 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). intervention 5: 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). intervention 6: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288


NCT02784288