NCT00918762

Brief Summary

RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors. PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

June 9, 2009

Last Update Submit

May 7, 2014

Conditions

Head and Neck CancerPerioperative/Postoperative ComplicationsPrecancerous Condition

Keywords

perioperative/postoperative complicationsprecancerous conditionstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

  • Operative time that directly affects operative cost

    post operative

Secondary Outcomes (12)

  • Blood loss

    During surgery

  • Intra-operative and post-operative complications

    during the operation and post operative

  • Need for reconstruction

    post operative

  • Margins status

    post operative

  • Length of hospital stay

    during time as inpatient

  • +7 more secondary outcomes

Study Arms (1)

daVinci® Robotic Surgical System

EXPERIMENTAL

Participants will undergo a planned surgical procedures via the robotic approach.

Procedure: assessment of therapy complicationsProcedure: diagnostic endoscopic surgeryProcedure: quality-of-life assessmentProcedure: therapeutic conventional surgeryProcedure: therapeutic endoscopic surgeryProcedure: transoral robotic surgeryProcedure: video-assisted surgery

Interventions

assessment of therapy complicationsPROCEDURE
daVinci® Robotic Surgical System
diagnostic endoscopic surgeryPROCEDURE
daVinci® Robotic Surgical System
quality-of-life assessmentPROCEDURE
daVinci® Robotic Surgical System
therapeutic conventional surgeryPROCEDURE
daVinci® Robotic Surgical System
therapeutic endoscopic surgeryPROCEDURE
daVinci® Robotic Surgical System
transoral robotic surgeryPROCEDURE
daVinci® Robotic Surgical System
video-assisted surgeryPROCEDURE
daVinci® Robotic Surgical System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes * Malignant disease must meet the following criteria: * Histologically confirmed diagnosis of 1 of the following: * Glottic cancer (T1, T2, and T3) * Supraglottic cancer (T1, T2, and T3) * Hypopharyngeal cancer (T1 and T2) * Oropharyngeal cancer (T1, T2, and T3) * Nasopharyngeal cancer (T1 and T2) * Resectable involved lymph nodes * No invasion of osseous and/or osseocartilaginous structures including the following: * Mandibular bone * Thyroid cartilage * Hyoid bone * Cricoid bone * Vertebral body * No pharyngeal wall or tongue-based involvement requiring resection of \> 50% of the posterior pharyngeal wall or tongue base * No radiological confirmation of carotid artery involvement * No fixation of tumor to the prevertebral fascia * No bilateral arytenoid involvement * No surgical defect requiring open approach for reconstruction * No evidence of distant metastasis PATIENT CHARACTERISTICS: * Not pregnant * No unexplained fever and/or untreated active infection * No medical conditions contraindicating general anesthesia * No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsPostoperative ComplicationsPrecancerous ConditionsSquamous Cell Carcinoma of Head and Neck

Interventions

Video-Assisted Surgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ho-Sheng Lin, MD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2010

Study Completion

October 1, 2010

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

US(1)