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

November 7, 2014 updated by: City of Hope Medical Center

Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients undergo transoral robotic microsurgery.
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: transoral robotic surgery
Undergo transoral robotic microsurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
From 6 months to 3 years after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
From 6 months to 3 years after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ellie Maghami, City of Hope Medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09206
  • NCI-2010-02169 (REGISTRY: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Squamous Cell Carcinoma of the Hypopharynx

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe