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Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck | Clinical Trials | Clareo Health

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

A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System

NCT01473784•Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
•The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
•Inability to grant informed consent
•Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally

Locations (1)

Ohio State University Medical Center

Columbus, Ohio, United States

Key Dates

Start Date

December 3, 2007

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

February 10, 2026

Enrollment

600

ESTIMATED participants

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage 0 Hypopharyngeal CancerStage 0 Laryngeal CancerStage 0 Lip and Oral Cavity CancerStage I Adenoid Cystic Carcinoma of the Oral CavityStage I Mucoepidermoid Carcinoma of the Oral CavityStage I Squamous Cell Carcinoma of the HypopharynxStage I Squamous Cell Carcinoma of the LarynxStage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Verrucous Carcinoma of the LarynxStage I Verrucous Carcinoma of the Oral CavityStage II Adenoid Cystic Carcinoma of the Oral CavityStage II Mucoepidermoid Carcinoma of the Oral CavityStage II Squamous Cell Carcinoma of the HypopharynxStage II Squamous Cell Carcinoma of the LarynxStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Verrucous Carcinoma of the LarynxStage II Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IVA Adenoid Cystic Carcinoma of the Oral CavityStage IVA Mucoepidermoid Carcinoma of the Oral CavityStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Adenoid Cystic Carcinoma of the Oral CavityStage IVB Mucoepidermoid Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Adenoid Cystic Carcinoma of the Oral CavityStage IVC Mucoepidermoid Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer

Interventions

transoral robotic surgery

PROCEDURE

quality of life assessment

PROCEDURE

Contacts

Ohio State University Comprehensive Cancer Center

CONTACT

1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Chelsea Marra

CONTACT

Chelseaanne.Marra@osumc.edu

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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