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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01473784

Collaborator

(none)

360

Enrollment

Location

Arm

168.9

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Dec 3, 2007

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Names: questionnaire

Arm

Intervention/Treatment

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 Names:

questionnaire

Outcome Measures

Primary Outcome Measures

Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [up to eight years]

Secondary Outcome Measures

Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. [up to eight years]
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. [up to eight years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
INTRAOPERATIVE EXCLUSION CRITERIA:
Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally