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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) (ORATOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590355
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 1, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date September 3, 2019
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
Quality of Life [ Time Frame: 1-year post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Overall Survival [ Time Frame: At the end of 3 years and at the end of 5 years ]
  • Progression-free survival [ Time Frame: At the end of 3 years and at the end of 5 years ]
  • Quality of life at other time points [ Time Frame: Every 6 months for 5 years from 1st date of treament ]
  • Toxicity [ Time Frame: 5 years from date of first treatment ]
  • Swallowing Function [ Time Frame: 5 years from date of first treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Official Title  ICMJE A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early-Stage Squamous Cell Carcinoma of the Oropharynx
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Radiotherapy plus or minus Chemotherapy
    Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease
    Intervention: Radiation: Radiotherapy
  • Experimental: 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.
    Intervention: Procedure: Transoral Robotic Surgery + Neck Dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 1, 2012)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590355
Other Study ID Numbers  ICMJE ORATOR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Palma, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Palma, MD, PhD London Regional Cancer Program of the Lawson Health Research Institute
Principal Investigator: Anthony Nichols, MD London Regional Cancer Program of the Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP