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

Phase 2

Active, not recruiting

• Conditions: Early-Stage Squamous Cell Carcinoma of the Oropharynx

• Registration Number: NCT01590355
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Study Start: 2012-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of Life	1-year post treatment

Secondary Outcome Measures

Name	Time	Method
Swallowing Function	5 years from date of first treatment
Toxicity	5 years from date of first treatment
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

Trial Locations

Locations (6)

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

London Regional Cancer Program of the Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada