Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

This study is currently recruiting participants.
Verified June 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Enver Ozer, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01473784
First received: November 7, 2011
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery


Condition Intervention
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage 0 Hypopharyngeal Cancer
Stage 0 Laryngeal Cancer
Stage 0 Lip and Oral Cavity Cancer
Stage I Adenoid Cystic Carcinoma of the Oral Cavity
Stage I Mucoepidermoid Carcinoma of the Oral Cavity
Stage I Squamous Cell Carcinoma of the Hypopharynx
Stage I Squamous Cell Carcinoma of the Larynx
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Verrucous Carcinoma of the Larynx
Stage I Verrucous Carcinoma of the Oral Cavity
Stage II Adenoid Cystic Carcinoma of the Oral Cavity
Stage II Mucoepidermoid Carcinoma of the Oral Cavity
Stage II Squamous Cell Carcinoma of the Hypopharynx
Stage II Squamous Cell Carcinoma of the Larynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Verrucous Carcinoma of the Larynx
Stage II Verrucous Carcinoma of the Oral Cavity
Stage III Adenoid Cystic Carcinoma of the Oral Cavity
Stage III Mucoepidermoid Carcinoma of the Oral Cavity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
Stage IVC Squamous Cell Carcinoma of the Larynx
Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVC Verrucous Carcinoma of the Larynx
Stage IVC Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Procedure: transoral robotic surgery
Procedure: quality of life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [ Time Frame: up to eight years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. [ Time Frame: up to eight years ] [ Designated as safety issue: Yes ]

    If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.

    2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.


  • Assess the quality of life of the patients with TORS. [ Time Frame: up to eight years ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: December 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
Procedure: transoral robotic surgery
Undergo TORS using the Da Vinci Robotic Surgical System
Other Names:
  • TORS
  • DA VINCI® ROBOTIC SURGICAL SYSTEM
Procedure: quality of life assessment
After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
Other Name: questionnaire

Detailed Description:

To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
  • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
  • Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion Criteria:

  • Unexplained fever and/or untreated, active infection
  • Patient pregnancy
  • Previous head and neck surgery precluding transoral/robotic procedures
  • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
  • Inability to grant informed consent
  • INTRAOPERATIVE EXCLUSION CRITERIA:
  • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473784

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Enver Ozer, MD 614-293-8074 enver.ozer@osumc.edu

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Enver Ozer, MD    614-293-8074    enver.ozer@osumc.edu   
Principal Investigator: Enver Ozer         
Sponsors and Collaborators
Enver Ozer
Investigators
Principal Investigator: Enver Ozer, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Enver Ozer, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01473784     History of Changes
Other Study ID Numbers: OSU-07061, NCI-2011-03122
Study First Received: November 7, 2011
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tongue Neoplasms
Carcinoma
Laryngeal Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Laryngeal Diseases
Mouth Neoplasms
Hypopharyngeal Neoplasms
Carcinoma in Situ
Carcinoma, Mucoepidermoid
Carcinoma, Verrucous
Lip Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Neoplasms, Squamous Cell
Adenocarcinoma
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Neoplasms, Cystic, Mucinous, and Serous
Lip Diseases

ClinicalTrials.gov processed this record on April 17, 2014