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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

Tracking Information
First Submitted Date  ICMJE November 3, 2010
First Posted Date  ICMJE December 7, 2010
Last Update Posted Date November 10, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • 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 ]
  • Assessment of the efficacy of TORS in patients with malignancies by studying oncologic outcomes in these patients as compared to data available in a comparable cancer population [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
Official Title  ICMJE Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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  ICMJE
  • 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
Study Arms  ICMJE Experimental: Arm I
Patients undergo transoral robotic microsurgery.
Interventions:
  • Procedure: transoral robotic surgery
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2014)		 7
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2010)		 50
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254734
Other Study ID Numbers  ICMJE 09206
NCI-2010-02169 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party City of Hope Medical Center
Original Responsible Party Maghami, Ellie, City of Hope Medical Center
Current Study Sponsor  ICMJE City of Hope Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ellie Maghami City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP