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

Primary Purpose

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transoral robotic surgery
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients undergo transoral robotic microsurgery.

Outcomes

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
Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors
Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors
Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS
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
Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors

Secondary Outcome Measures

Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.
Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments

Full Information

First Posted
November 3, 2010
Last Updated
November 7, 2014
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01254734
Brief Title
Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
Official Title
Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
The study will be rewritten as a data registry study
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo transoral robotic microsurgery.
Intervention Type
Procedure
Intervention Name(s)
transoral robotic surgery
Intervention Description
Undergo transoral robotic microsurgery
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellie Maghami
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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