Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer

City of Hope

Status

Terminated

Conditions

Recurrent Squamous Cell Carcinoma of the Hypopharynx

Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage IV Lymphoepithelioma of the Oropharynx

Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Adenoid Cystic Carcinoma of the Oral Cavity

Stage IV Squamous Cell Carcinoma of the Oropharynx

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 II Lymphoepithelioma of the Oropharynx

Stage II Verrucous Carcinoma of the Oral Cavity

Recurrent Squamous Cell Carcinoma of the Oropharynx

Stage IV Squamous Cell Carcinoma of the Hypopharynx

Stage I Squamous Cell Carcinoma of the Hypopharynx

Stage II Squamous Cell Carcinoma of the Larynx

Stage I Lymphoepithelioma of the Oropharynx

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Verrucous Carcinoma of the 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 III Squamous Cell Carcinoma of the Oropharynx

Stage I Adenoid Cystic Carcinoma of the Oral Cavity

Stage IV Mucoepidermoid Carcinoma of the Oral Cavity

Stage II Adenoid Cystic Carcinoma of the Oral Cavity

Stage III Lymphoepithelioma of the Nasopharynx

Recurrent Lymphoepithelioma of the Nasopharynx

Stage III Squamous Cell Carcinoma of the Hypopharynx

Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Stage I Verrucous Carcinoma of the Larynx

Stage IV Adenoid Cystic Carcinoma of the Oral Cavity

Stage I Squamous Cell Carcinoma of the Nasopharynx

Stage IV Squamous Cell Carcinoma of the Larynx

Recurrent Verrucous Carcinoma of the Oral Cavity

Stage IV Lymphoepithelioma of the Nasopharynx

Recurrent Lymphoepithelioma of the Oropharynx

Stage I Squamous Cell Carcinoma of the Oropharynx

Stage IV Verrucous Carcinoma of the Larynx

Stage IV Verrucous Carcinoma of the Oral Cavity

Stage III Verrucous Carcinoma of the Larynx

Stage II Lymphoepithelioma of the Nasopharynx

Stage III Squamous Cell Carcinoma of the Nasopharynx

Recurrent Squamous Cell Carcinoma of the Larynx

Stage III Lymphoepithelioma of the Oropharynx

Stage II Verrucous Carcinoma of the Larynx

Stage I Squamous Cell Carcinoma of the Larynx

Stage II Squamous Cell Carcinoma of the Oropharynx

Stage III Squamous Cell Carcinoma of the Larynx

Recurrent Squamous Cell Carcinoma of the Nasopharynx

Stage IV Squamous Cell Carcinoma of the Nasopharynx

Stage II Squamous Cell Carcinoma of the Nasopharynx

Stage I Lymphoepithelioma of the Nasopharynx

Treatments

Procedure: quality-of-life assessment

Procedure: transoral robotic surgery

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01254734

NCI-2010-02169 (Registry Identifier)

09206

Details and patient eligibility

About

RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.

Full description

PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
Surgical access is amenable to treatment with conventional transoral surgical procedures
ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
Patients should have no serious acute infection
Patients must sign a study-specific informed consent form

Exclusion criteria

Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
ASA score > 4; ECOG PS score > 3
Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
The presence of medical conditions which contraindicate general anesthesia
Unexplained fever or untreated, active infection
Inability to obtain exposure to allow performance of the planned transoral surgical procedure
Proposed surgical site with history of prior treatment: radiation
Tumor adherent to carotid artery or jugular vein
Fixation to pre-vertebral tumor
Mandibular invasion