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

This study is currently recruiting participants.
Verified January 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01254734
First received: November 3, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
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
Procedure: transoral robotic surgery
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival. [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: No ]
  • Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo transoral robotic microsurgery.
Procedure: transoral robotic surgery
Undergo transoral robotic microsurgery
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254734

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Ellie Maghami    800-826-4673    emaghami@coh.org   
Principal Investigator: Ellie Maghami         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Ellie Maghami City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01254734     History of Changes
Other Study ID Numbers: 09206, NCI-2010-02169
Study First Received: November 3, 2010
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Laryngeal Diseases
Carcinoma, Mucoepidermoid
Carcinoma, Verrucous
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Adenocarcinoma
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neoplasms, Cystic, Mucinous, and Serous
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Neoplasms
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on April 16, 2014