Primary Radiotherapy Versus Primary Surgery for HPV-Associated

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03210103
Study type	Interventional
Source	Lawson Health Research Institute
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 26, 2018
Completion date	August 15, 2028

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See also
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Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer — ORATOR2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms