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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01590355
First received: May 1, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Early-Stage Squamous Cell Carcinoma of the Oropharynx
Radiation: Radiotherapy
Procedure: Transoral Robotic Surgery + Neck Dissection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 1-year post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: At the end of 3 years and at the end of 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: At the end of 3 years and at the end of 5 years ] [ Designated as safety issue: No ]
  • Quality of life at other time points [ Time Frame: Every 6 months for 5 years from 1st date of treament ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 5 years from date of first treatment ] [ Designated as safety issue: No ]
  • Swallowing Function [ Time Frame: 5 years from date of first treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: June 2012
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 (<=3cm), or N2 (up to 2 nodes between 1-3cm, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590355

Contacts
Contact: David Palma 519-685-8500 david.palma@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Palma, MD, PhD    519-685-8650    david.palma@lhsc.on.ca   
Principal Investigator: David Palma, MD, PhD         
Principal Investigator: Anthony Nichols, MD         
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

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01590355     History of Changes
Other Study ID Numbers: ORATOR
Study First Received: May 1, 2012
Last Updated: September 25, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
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

ClinicalTrials.gov processed this record on September 30, 2014