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

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:

Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01254734
• Other study ID #: 09206
• Secondary ID: NCI-2010-02169
• Status: Terminated
• Phase: N/A
• First received: November 3, 2010
• Last updated: November 7, 2014
• Start date: April 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenoid Cystic
• Carcinoma, Squamous Cell
• Laryngeal Diseases
• Laryngeal Neoplasms
• Nasopharyngeal Neoplasms
• Oropharyngeal Neoplasms
• Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
• Recurrent Lymphoepithelioma of the Nasopharynx
• Recurrent Lymphoepithelioma of the Oropharynx
• 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 Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Stage I Adenoid Cystic Carcinoma of the Oral Cavity
• Stage I Lymphoepithelioma of the Nasopharynx
• Stage I Lymphoepithelioma of the Oropharynx
• 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 Squamous Cell Carcinoma of the Nasopharynx
• Stage I Squamous Cell Carcinoma of the Oropharynx
• 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 Lymphoepithelioma of the Nasopharynx
• Stage II Lymphoepithelioma of the Oropharynx
• 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 Squamous Cell Carcinoma of the Nasopharynx
• Stage II Squamous Cell Carcinoma of the Oropharynx
• 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 Lymphoepithelioma of the Nasopharynx
• Stage III Lymphoepithelioma of the Oropharynx
• 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 Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Verrucous Carcinoma of the Larynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Oropharynx
• Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Verrucous Carcinoma of the Larynx
• Stage IV Verrucous Carcinoma of the Oral Cavity

Intervention

Procedure:
• transoral robotic surgery
Undergo transoral robotic microsurgery

Other:
• laboratory biomarker analysis
Correlative studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors		From 6 months to 3 years after completion of study treatment	Yes
Primary	Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors		From 6 months to 3 years after completion of study treatment	Yes
Primary	Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors		From 6 months to 3 years after completion of study treatment	Yes
Primary	Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS		From 6 months to 3 years after completion of study treatment	Yes
Primary	Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors		From 6 months to 3 years after completion of study treatment	Yes
Primary	Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors		From 6 months to 3 years after completion of study treatment	Yes
Secondary	Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.		From 6 months to 3 years after completion of study treatment	No
Secondary	Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments		From 6 months to 3 years after completion of study treatment	No