RECRUITING

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

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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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2007-12-03
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01473784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
  3. * Written informed consent and/or Consent waiver by institutional review board (IRB)
  1. * Unexplained fever and/or untreated, active infection
  2. * Patient pregnancy
  3. * 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.
  4. * The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
  5. * Inability to grant informed consent
  6. * INTRAOPERATIVE

Contacts and Locations

Study Contact

Ohio State University Comprehensive Cancer Center
CONTACT
1-800-293-5066
OSUCCCClinicaltrials@osumc.edu
Chelsea Marra
CONTACT
Chelseaanne.Marra@osumc.edu

Principal Investigator

Enver Ozer, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

Ohio State University Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Enver Ozer, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-12-03
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2007-12-03
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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