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

The Ohio State University

Status: Enrolling

Conditions: Recurrent Squamous Cell Carcinoma of the Hypopharynx; Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity; Stage III Adenoid Cystic Carcinoma of the Oral Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Recurrent Verrucous Carcinoma of the Larynx; Stage 0 Laryngeal Cancer; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage I Squamous Cell Carcinoma of the Hypopharynx; Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity; Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity; Stage II Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Verrucous Carcinoma of the Oral Cavity; Tongue Cancer; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Squamous Cell Carcinoma of the Hypopharynx; Stage I Mucoepidermoid Carcinoma of the Oral Cavity; Stage III Mucoepidermoid Carcinoma of the Oral Cavity; Stage II Mucoepidermoid Carcinoma of the Oral Cavity; Stage I Verrucous Carcinoma of the Oral Cavity; Stage I Adenoid Cystic Carcinoma of the Oral Cavity; Stage 0 Hypopharyngeal Cancer; Stage IVC Verrucous Carcinoma of the Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage II Adenoid Cystic Carcinoma of the Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Hypopharynx; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Stage I Verrucous Carcinoma of the Larynx; Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity; Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity; Stage 0 Lip and Oral Cavity Cancer; Stage IVB Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Verrucous Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Larynx; Stage II Verrucous Carcinoma of the Larynx; Stage I Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity

Treatments: Procedure: quality of life assessment; Procedure: transoral robotic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01473784

OSU-07061

NCI-2011-03122 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

600 participants in 1 patient group

Transoral robotic surgery (TORS)

Experimental group

Description:

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.

Treatment:

Procedure: quality of life assessment

Procedure: transoral robotic surgery