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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254734
Recruitment Status : Terminated (The study will be rewritten as a data registry study)
First Posted : December 7, 2010
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
Study Start Date : April 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254734


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ellie Maghami City of Hope Medical Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01254734    
Other Study ID Numbers: 09206
NCI-2010-02169 ( Registry Identifier: NCI CTRP )
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Squamous Cell Carcinoma of Head and Neck
Nasopharyngeal Carcinoma
Carcinoma, Adenoid Cystic
Carcinoma, Mucoepidermoid
Mucoepidermoid Tumor
Laryngeal Diseases
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Disease Attributes
Pathologic Processes
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Adenocarcinoma