Status:
TERMINATED
Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Lymphoepithelioma of the Nasopharynx
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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, hospitali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01254734
Start Date
April 1 2011
End Date
November 1 2014
Last Update
November 10 2014
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010