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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Early-Stage Squamous Cell Carcinoma of the Oropharynx	Radiation: Radiotherapy; Procedure: Transoral Robotic Surgery + Neck Dissection	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	68 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Study Start Date :	June 2012
Estimated Primary Completion Date :	June 2021
Estimated Study Completion Date :	June 2021

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Radiotherapy plus or minus Chemotherapy; Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease	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
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; Transoral robotic excision will be carried out using the da Vinci surgical robot.

Outcome Measures

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Primary Outcome Measures :

1. Quality of Life [ Time Frame: 1-year post treatment ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01590355 History of Changes
Other Study ID Numbers:	ORATOR
First Posted:	May 2, 2012
Last Update Posted:	August 4, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Oropharyngeal Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell	Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases