Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- Oropharyngeal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 2 Arm study randomized in a 1:1 ratioMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 subsequen...
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
Tracking Information
- NCT #
- NCT03210103
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Palma Lawson Health Research Institute
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