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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)

Primary Purpose

Early-Stage Squamous Cell Carcinoma of the Oropharynx

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radiotherapy
Transoral Robotic Surgery + Neck Dissection
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Stage Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Adelaide Hospital
  • British Columbia Cancer Agency
  • London Regional Cancer Program of the Lawson Health Research Institute
  • The Ottawa Hospital Cancer Centre
  • University Health Network
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy plus or minus Chemotherapy

Transoral Robotic Surgery + Neck Dissection

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Quality of Life

Secondary Outcome Measures

Overall Survival
Progression-free survival
Quality of life at other time points
Toxicity
Swallowing Function

Full Information

First Posted
May 1, 2012
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01590355
Brief Title
A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Acronym
ORATOR
Official Title
A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Stage Squamous Cell Carcinoma of the Oropharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy plus or minus Chemotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease
Arm Title
Transoral Robotic Surgery + Neck Dissection
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Transoral Robotic Surgery + Neck Dissection
Intervention Description
Transoral robotic excision will be carried out using the da Vinci surgical robot.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
1-year post treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
At the end of 3 years and at the end of 5 years
Title
Progression-free survival
Time Frame
At the end of 3 years and at the end of 5 years
Title
Quality of life at other time points
Time Frame
Every 6 months for 5 years from 1st date of treament
Title
Toxicity
Time Frame
5 years from date of first treatment
Title
Swallowing Function
Time Frame
5 years from date of first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Palma, MD, PhD
Organizational Affiliation
London Regional Cancer Program of the Lawson Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Nichols, MD
Organizational Affiliation
London Regional Cancer Program of the Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4E6
Country
Canada
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34995124
Citation
Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, Fung K, de Almeida JR, Bayley A, Goldstein DP, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Winquist E, Hammond JA, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Chen J, Corsten M, Johnson-Obaseki S, Odell M, Parker C, Wehrli B, Kwan K, Palma DA. Randomized Trial of Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Long-Term Results of the ORATOR Trial. J Clin Oncol. 2022 Mar 10;40(8):866-875. doi: 10.1200/JCO.21.01961. Epub 2022 Jan 7.
Results Reference
derived
PubMed Identifier
31416685
Citation
Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, Fung K, de Almeida JR, Bayley A, Goldstein DP, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Winquist E, Hammond JA, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Chen J, Corsten M, Johnson-Obaseki S, Eapen L, Odell M, Parker C, Wehrli B, Kwan K, Palma DA. Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial. Lancet Oncol. 2019 Oct;20(10):1349-1359. doi: 10.1016/S1470-2045(19)30410-3. Epub 2019 Aug 12. Erratum In: Lancet Oncol. 2019 Dec;20(12):e663.
Results Reference
derived
PubMed Identifier
23514246
Citation
Nichols AC, Yoo J, Hammond JA, Fung K, Winquist E, Read N, Venkatesan V, MacNeil SD, Ernst DS, Kuruvilla S, Chen J, Corsten M, Odell M, Eapen L, Theurer J, Doyle PC, Wehrli B, Kwan K, Palma DA. Early-stage squamous cell carcinoma of the oropharynx: radiotherapy vs. trans-oral robotic surgery (ORATOR)--study protocol for a randomized phase II trial. BMC Cancer. 2013 Mar 20;13:133. doi: 10.1186/1471-2407-13-133.
Results Reference
derived

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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)

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