Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
This study is currently recruiting participants.
Verified March 2013 by City of Hope Medical Center
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01254734
First received: November 3, 2010
Last updated: March 6, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 the transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
| Condition | Intervention |
|---|---|
|
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 |
Procedure: transoral robotic surgery Other: laboratory biomarker analysis Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors |
Resource links provided by NLM:
Further study details as provided by City of Hope Medical Center:
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 [ Time Frame: From 6 months to 3 years after completion of study treatment ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo transoral robotic microsurgery.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254734
Locations
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Ellie Maghami 800-826-4673 emaghami@coh.org | |
| Principal Investigator: Ellie Maghami | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Principal Investigator: | Ellie Maghami | City of Hope Medical Center |
More Information
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01254734 History of Changes |
| Other Study ID Numbers: | 09206, NCI-2010-02169 |
| Study First Received: | November 3, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Adenocarcinoma Neoplasms by Site Respiratory Tract Diseases Otorhinolaryngologic Diseases Neoplasms, Cystic, Mucinous, and Serous Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Neoplasms Nasopharyngeal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013