The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial
The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial The study will compare overall survival rates relative to historical controls for de-intensified primary radiotherapy \[60 GY +/- chemotherapy\] versus transoral surgery (TOS) and neck dissection \[+/- adjuvant 50Gy radiotherapy\] in patients with early T-stage HPV-positive squamous cell carcinoma of the oropharynx and to compare quality of life (QOL) profiles. The study will require a sample size of 140 patients randomized in a 1:1 ratio between the two arms. Arm 1 (radiotherapy +/1 chemotherapy) and Arm 2 (TOS) Patients will be followed for a total of 5 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Standard of Care: Radiation +/- Chemotherapy
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BC Cancer
Vancouver, British Columbia, Canada
Overall Survival
Time from randomization to death from any cause
Time frame: 2 years
Quality of Life 1 year post treatment
Quality of life 1 year post treatment as assessed with the MD Anderson Dysphagia Inventory (MDADI)
Time frame: 1 year post treatment
Progression free survival comparison with historical controls
Defined as time from randomization to death from any cause
Time frame: 5 years
Quality of life
Quality of Life using the following questionnaire: MD Anderson Dysphagia Inventory (MDADI)
Time frame: Baseline to 5 years follow up
Quality of life
Quality of Life using the following questionnaire: EORTC QLQ C30
Time frame: Baseline to 5 years follow up
Quality of life
Quality of Life using the following questionnaire: H\&N35 scale
Time frame: Baseline to 5 years follow up
Quality of life
Quality of Life using the following questionnaire: Voice Handicap Index (VHI-10)
Time frame: Baseline to 5 years follow up
Quality of life
Quality of Life using the following questionnaire: Neck Dissection Impairment Index (NDII)
Time frame: Baseline to 5 years follow up
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London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Quality of life
Quality of Life using the following questionnaire: Patient Neurotoxicity Questionnaire (PNQ)
Time frame: Baseline to 5 years follow up
toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
To determine to toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
Time frame: Randomization until 5 years follow up
Feeding tube rate at 1 year
Measure other functional measurements such as feeding tube rate at 1 year
Time frame: baseline to 1 year post treatment
CTCAE Dysphagia grade
Measure other functional measurements such as CTCAE Dysphagia grade
Time frame: baseline to 5 years post treatment
Speech intelligibility
Measure other functional measurements such as speech intelligibility
Time frame: baseline to 5 years post treatment
Normalcy of diet
Measure other functional measurements such as normalcy of diet
Time frame: baseline to 5 years post treatment
2 year progression-free survival comparison between Arm 1 and Arm 2
Time from randomization to disease progress at any site or death from any cause
Time frame: 2 years