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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)

NCT01590355 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

  • Early-Stage Squamous Cell Carcinoma of the Oropharynx

Interventions

RADIATION

Radiotherapy

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

PROCEDURE

Transoral Robotic Surgery + Neck Dissection

Transoral robotic excision will be carried out using the da Vinci surgical robot.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • David Palma, MD, PhD · London Regional Cancer Program of the Lawson Health Research Institute

  • Anthony Nichols, MD · London Regional Cancer Program of the Lawson Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01590355 on ClinicalTrials.gov