A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)

Study Overview
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Brief Summary
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The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation. This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.

Official Title
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A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)

Conditions
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Early-Stage Squamous Cell Carcinoma of the Oropharynx

Intervention / Treatment
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* Radiation: Radiotherapy
* Procedure: Transoral Robotic Surgery + Neck Dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older willing to provide informed consent ECOG performance status 0-2 Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) Tumour stage:T1 or T2, with likely negative resections at surgery Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging. Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization. Exclusion Criteria: Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery Prior history of head and neck cancer within 5 years Prior head and neck radiation at any time Metastatic disease Inability to attend full course of radiotherapy or follow-up visits Neck disease with unknown primary site Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer unable or unwilling to complete QoL questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy plus or minus Chemotherapy<br>Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease | Radiation: Radiotherapy<br>* Gross Tumour and Nodes: 70 Gy in 35 fractions over 7 weeks. High-risk nodal areas: 63 Gy in 35 fractions over 7 weeks. Low-risk nodal areas: 56 Gy in 35 fractions over 7 weeks<br>|
| Experimental: Transoral Robotic Surgery + Neck Dissection<br>Transoral robotic excision will be carried out using the da Vinci surgical robot. The spatula cautery will be used to remove the tumours with 1 cm margins. At the time of surgery circumferential margins will be taken and sent for frozen section analysis. The resection will proceed until negative margins are obtained if feasible. | Procedure: Transoral Robotic Surgery + Neck Dissection<br>* Transoral robotic excision will be carried out using the da Vinci surgical robot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 1-year post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | At the end of 3 years and at the end of 5 years | 
| Progression-free survival |  | At the end of 3 years and at the end of 5 years | 
| Quality of life at other time points |  | Every 6 months for 5 years from 1st date of treament | 
| Toxicity |  | 5 years from date of first treatment | 
| Swallowing Function |  | 5 years from date of first treatment |