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Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

NCT02225496 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-12-15

No results posted yet for this study

Summary

Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects.

The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.

Researchers also want to learn if this surgery affects participants' ability to speak and swallow.

Conditions

  • Oropharyngeal Cancer

Interventions

PROCEDURE

Transoral Robotic Surgery (TORS)

Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.

PROCEDURE

Modified Barium Swallow (MBS)

MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.

BEHAVIORAL

Questionnaires

Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael E. Kupferman, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2017-12-08
Completion
2017-12-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225496 on ClinicalTrials.gov