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

Lawson Health Research Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Early-Stage Squamous Cell Carcinoma of the Oropharynx

Treatments: Procedure: Transoral Robotic Surgery + Neck Dissection; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01590355

ORATOR

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Radiotherapy plus or minus Chemotherapy

Active Comparator group

Description:

Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease

Treatment:

Radiation: Radiotherapy

Transoral Robotic Surgery + Neck Dissection

Experimental group

Description:

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.

Treatment:

Procedure: Transoral Robotic Surgery + Neck Dissection