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Status unknownNCT01590355ORATORUpdated Mar 8, 2023

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

A Phase 2 interventional study of Radiotherapy and Transoral Robotic Surgery + Neck Dissection in Early-Stage Squamous Cell Carcinoma of the Oropharynx, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Status unknown at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Early-Stage Squamous Cell Carcinoma of the Oropharynx
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 68 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Radiotherapy plus or minus Chemotherapy

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

    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.

    Procedure: Transoral Robotic Surgery + Neck Dissection

Interventions

  • RadiationRadiotherapy

    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

  • ProcedureTransoral Robotic Surgery + Neck Dissection

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

06

What researchers measure

Primary outcomes

  1. Quality of Life

    Time frame: 1-year post treatment

Secondary outcomes

  1. Overall Survival

    Time frame: At the end of 3 years and at the end of 5 years

  2. Progression-free survival

    Time frame: At the end of 3 years and at the end of 5 years

  3. Quality of life at other time points

    Time frame: Every 6 months for 5 years from 1st date of treament

  4. Toxicity

    Time frame: 5 years from date of first treatment

  5. Swallowing Function

    Time frame: 5 years from date of first treatment

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Study locations

6 sites
  • Royal Adelaide Hospital
    Adelaide, 5000, Australia
  • British Columbia Cancer Agency
    Vancouver, British Columbia V5Z4E6, Canada
  • London Regional Cancer Program of the Lawson Health Research Institute
    London, Ontario N6A 4L6, Canada
  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario K1H 8L6, Canada
  • University Health Network
    Toronto, Ontario M5G2M9, Canada
  • Jewish General Hospital
    Montréal, Quebec H3T 1E2, Canada
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References and documents

Publications

  • 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. PubMed 34995124 ↗
  • 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. doi: 10.1016/S1470-2045(19)30725-9. PubMed 31416685 ↗
  • 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. PubMed 23514246 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01590355
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party
David Palma (Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
May 2, 2012
Start date
Jun 2012
Primary completion
Sep 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Mar 8, 2023

Study contacts

David Palma, MD, PhD
principal investigator · London Regional Cancer Program of the Lawson Health Research Institute
Anthony Nichols, MD
principal investigator · London Regional Cancer Program of the Lawson Health Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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