A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
- Conditions
- Early-Stage Squamous Cell Carcinoma of the Oropharynx
- Interventions
- Radiation: RadiotherapyProcedure: Transoral Robotic Surgery + Neck Dissection
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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
- Arm && Interventions
Group Intervention Description Radiotherapy plus or minus Chemotherapy Radiotherapy Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease Transoral Robotic Surgery + Neck Dissection Transoral Robotic Surgery + Neck Dissection 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.
- 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