Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
This study is currently recruiting participants.
Verified November 2011 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01473784
First received: November 7, 2011
Last updated: November 14, 2011
Last verified: November 2011
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Purpose
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery
| Condition | Intervention |
|---|---|
|
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity 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 Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Stage 0 Hypopharyngeal Cancer Stage 0 Laryngeal Cancer Stage 0 Lip and Oral Cavity Cancer Stage I Adenoid Cystic Carcinoma of the Oral Cavity 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 Verrucous Carcinoma of the Larynx Stage I Verrucous Carcinoma of the Oral Cavity Stage II Adenoid Cystic Carcinoma of the Oral Cavity 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 Verrucous Carcinoma of the Larynx Stage II Verrucous Carcinoma of the Oral Cavity Stage III Adenoid Cystic Carcinoma of the Oral Cavity 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 Verrucous Carcinoma of the Larynx Stage III Verrucous Carcinoma of the Oral Cavity Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity Stage IVA Squamous Cell Carcinoma of the Larynx Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVA Verrucous Carcinoma of the Larynx Stage IVA Verrucous Carcinoma of the Oral Cavity Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity Stage IVB Squamous Cell Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVB Verrucous Carcinoma of the Larynx Stage IVB Verrucous Carcinoma of the Oral Cavity Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity Stage IVC Squamous Cell Carcinoma of the Larynx Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVC Verrucous Carcinoma of the Larynx Stage IVC Verrucous Carcinoma of the Oral Cavity Tongue Cancer |
Procedure: transoral robotic surgery Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System |
Resource links provided by NLM:
Further study details as provided by Ohio State University Comprehensive Cancer Center:
Primary Outcome Measures:
- Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [ Time Frame: 2007-present ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. [ Time Frame: 2007-present ] [ Designated as safety issue: Yes ]
If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.
2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.
- Assess the quality of life of the patients with TORS. [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (surgery)
Patients undergo TORS using the Da Vinci Robotic Surgical System.
|
Procedure: transoral robotic surgery
Undergo TORS using the Da Vinci Robotic Surgical System
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
Detailed Description:
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
- Written informed consent and/or Consent waiver by institutional review board (IRB)
Exclusion Criteria:
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery precluding transoral/robotic procedures
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
- Inability to grant informed consent
- INTRAOPERATIVE EXCLUSION CRITERIA:
- Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473784
Contacts
| Contact: Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | Jamesline@osumc.edu |
| Contact: Enver Ozer, MD | 614-293-8074 | enver.ozer@osumc.edu |
Locations
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Enver Ozer 614-293-8074 enver.ozer@osumc.edu | |
| Principal Investigator: Enver Ozer | |
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
| Principal Investigator: | Enver Ozer | Ohio State University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01473784 History of Changes |
| Other Study ID Numbers: | OSU-07061, NCI-2011-03122 |
| Study First Received: | November 7, 2011 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Laryngeal Neoplasms Carcinoma, Squamous Cell Carcinoma, Adenoid Cystic Head and Neck Neoplasms Laryngeal Diseases Mouth Neoplasms Tongue Neoplasms Hypopharyngeal Neoplasms Carcinoma in Situ Carcinoma, Mucoepidermoid Carcinoma, Verrucous Lip Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Otorhinolaryngologic Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases Neoplasms, Squamous Cell Adenocarcinoma Mouth Diseases Stomatognathic Diseases Tongue Diseases Pharyngeal Neoplasms Pharyngeal Diseases Neoplasms, Cystic, Mucinous, and Serous Lip Diseases |
ClinicalTrials.gov processed this record on May 22, 2013