| Trial name or title |
'Phase II randomized trial of transoral surgical resection followed by low‐dose or standard‐dose IMRT in resectable p16+ locally advanced oropharynx cancer' |
| Methods |
Parallel‐group randomised controlled trial |
| Participants |
Inclusion criteria:
18 years and older Registration to the surgery arm of the trial Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx; oropharyngeal disease must be resectable American Joint Committee on Cancer (AJCC) TNM tumour stage III, IVa or IVb (with no evidence of distant metastases) as determined by imaging studies (performed < 4 weeks prior to pre‐registration) and complete head and neck examination Biopsy‐proven cyclin‐dependent kinase inhibitor 2A (p16)+ oropharyngeal cancer from either primary tumour or metastatic lymph node (p16 expression determined using immunohistochemistry) Nodal disease stage N1‐N2b No prior radiation above the clavicles Histopathological assessment of surgical pathology must include examination for perineural invasion, lymphovascular invasion and extracapsular extension/spread
Exclusion criteria:
Primary or nodal disease fixed to the carotid artery, skull base or cervical spine Patients with N0 disease Prior invasive malignancy (except non‐melanomatous skin cancer) unless disease‐free for at least 2 years Intercurrent illness likely to interfere with protocol therapy or prevent surgical resection Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days of registration
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| Interventions |
Intervention group A (TOS): patients undergo transoral surgical resection of the oropharyngeal tumour
Intervention group B (TOS, low‐dose IMRT): patients undergo transoral surgical resection of the oropharyngeal tumour. Patients then undergo low‐dose IMRT 5 days a week for 5 weeks.
Intervention group C (TOS, standard‐dose IMRT): patients undergo transoral surgical resection of the oropharyngeal tumour. Patients then undergo standard‐dose IMRT 5 days a week for 6 weeks.
Intervention group D (TOS, standard‐dose IMRT, chemotherapy): patients undergo transoral surgical resection of the oropharyngeal tumour. Patients then undergo standard‐dose IMRT 5 days a week for 6 to 7 weeks. Patients also receive cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36 and 43 during radiation therapy. |
| Outcomes |
Primary outcomes:
Progression‐free survival rate: defined as the proportion of patients alive and progression‐free (time frame: 2 years) Accrual rate (time frame: 18 months) Risk distribution: 90% binomial confidence interval will be estimated for the % of patients in each risk group (time frame: 18 months) Incidence grade 3‐4 bleeding events during surgery and positive margins after surgery, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4) (time frame: 18 months)
Secondary outcomes:
Incidence of adverse events evaluated by NCI CTCAE v4 (time frame: 3 years) Overall survival (time frame: 3 years) Swallowing function before and after treatment, evaluated using the modified barium swallow (MBS) ratings, performance status scale for head and neck cancer (PSS‐HN) normalcy of diet scale and the MD Anderson Dysphagia Inventory (MDADI) (time frame: 2 years) Voice before and after treatment, evaluated using the Voice Handicap Index‐10 (time frame: 2 years) Change in patient‐reported quality of life as measured using the Functional Assessment of Cancer Therapy – Head and Neck (time frame: baseline to 6 months post RT)
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| Starting date |
10 July 2013 |
| Contact information |
Primary investigator: Robert Ferris MD
Eastern Cooperative Oncology Group |
| Notes |
https://clinicaltrials.gov/ct2/show/study/NCT01898494 |
