Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
NCT ID: NCT02225496
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2014-09-23
2017-12-08
Brief Summary
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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.
Detailed Description
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If you are found to be eligible to take part in this study, you will be scheduled for surgery. You will receive general anesthesia to make you sleep during the procedure. You will be asked to sign a separate consent form that describes the anesthesia and its risks. If the doctor thinks it is needed, the abnormal area will be looked at with a tube that has a lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look for any additional cancerous areas.
The tumor will be exposed with standard equipment after the teeth are protected with a dental guard. Using the robotic surgical system, the tumor will be removed.
Your affected lymph nodes will be surgically removed through your neck. The robotic system will not be used for that part of the surgery. The nerve that controls the shoulder, the blood vessel that brings blood back to the heart from the brain and neck, and the major muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has grown directly into those areas. A drain will be placed before the surgical wound is closed. The drain will usually be removed within a week after surgery.
Based on the results of surgery, you will receive adjuvant therapy (therapy after the surgery). For example, if your surgery does not remove enough of the cancer, you will be referred to receive radiation therapy. There will likely need to be a 1-2 week delay before you can receive radiation therapy. Your doctor will discuss this therapy with you in more detail, including the risks.
Length of Study:
The surgery will be stopped if the doctor thinks the tumor is too large to be removed with the robotic system. You will be taken off study if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits and data collection.
Follow-Up Visits:
Within 1-4 weeks after surgery (+/- 3 days):
* You will have a physical exam, including a cranial nerve exam of your tongue, palate, and facial nerves.
* You will have an MBS.
* You will meet with a speech pathologist.
* You will complete the questionnaires about your speech and swallowing function.
At 6 months (+/- 2 months), 12 months (+/- 2 months), and 24 months (+/- 6 months) after surgery:
* You will have an MBS.
* You will have a cranial nerve exam of your tongue, palate, and facial nerves.
* You will meet with a speech pathologist.
* You will complete the questionnaires about your speech and swallowing function.
As often as the doctor thinks it is needed for up to 5 years after surgery, the study staff will check your medical record to find out how you are doing and about any treatments and follow-up you have had.
This is an investigational study. The robotic surgical procedure (the daVinci Surgical System) is FDA approved and commercially available. The study doctor can explain how the surgery is designed to work.
Up to 150 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow \[MBS\] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
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.
Modified Barium Swallow (MBS)
MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
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.
Interventions
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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.
Modified Barium Swallow (MBS)
MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) PS 0-2.
3. Age \>/= 18 years.
4. Negative serum pregnancy test in females of childbearing potential.
5. Patients must sign a study-specific informed consent form prior to treatment.
Exclusion Criteria
2. Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or bony invasion, which would preclude TMIS by clinical and/or radiographic exam.
3. Contraindications to general anesthesia.
4. Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
6. Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael E. Kupferman, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2014-02126
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-0925
Identifier Type: -
Identifier Source: org_study_id