Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Standard Treatment (Radiation +/- Chemotherapy)

Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)

Standard of Care: Radiation +/- Chemotherapy

Radiation

Transoral Surgery (TOS) + Neck Dissection

David Palma

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

Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR II)

Time from randomization to death from any cause

Quality of life 1 year post treatment as assessed with the MD Anderson Dysphagia Inventory (MDADI)

Defined as time from randomization to death from any cause

Quality of Life using the following questionnaire: MD Anderson Dysphagia Inventory (MDADI)

Quality of Life using the following questionnaire: EORTC QLQ C30

Quality of Life using the following questionnaire: H\&N35 scale

Quality of Life using the following questionnaire: Voice Handicap Index (VHI-10)

Quality of Life using the following questionnaire: Neck Dissection Impairment Index (NDII)

Quality of Life using the following questionnaire: Patient Neurotoxicity Questionnaire (PNQ)

To determine to toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4

Measure other functional measurements such as feeding tube rate at 1 year

Measure other functional measurements such as CTCAE Dysphagia grade

Measure other functional measurements such as speech intelligibility

Measure other functional measurements such as normalcy of diet

Time from randomization to disease progress at any site or death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer	NCT03210103	Oropharyngeal C...	Radiation Transoral Surge...	18 Years -	Lawson Health Research Institute
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer	NCT03210103	Oropharyngeal C...	Radiation Transoral Surge...	18 Years -	Lawson Health Research Institute

Spots Global Cancer Trial Database for transoral surgery (tos) + neck dissection