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Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors


N/A
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

From 6 months to 3 years after completion of study treatment

Safety Issue:

Yes

Principal Investigator

Ellie Maghami

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09206

NCT ID:

NCT01254734

Start Date:

April 2011

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenoid Cystic
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Carcinoma, Mucoepidermoid
  • Carcinoma, Verrucous
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010