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

ConditionsRecurrent 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
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • transoral robotic surgery

    Procedure/Surgery

    Undergo TORS using the Da Vinci Robotic Surgical System

  • quality of life assessment

    Procedure/Surgery

    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.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Transoral robotic surgery (TORS)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.

Time frame
up to eight years

Secondary outcomes

1

Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.

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.

Time frame
up to eight years
2

Assess the quality of life of the patients with TORS.

Time frame
up to eight years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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