Status:
TERMINATED
Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Oropharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) app...
Detailed Description
Study Surgery: 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 a...
Eligibility Criteria
Inclusion
- Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx.
- Eastern Cooperative Oncology Group (ECOG) PS 0-2.
- Age \>/= 18 years.
- Negative serum pregnancy test in females of childbearing potential.
- Patients must sign a study-specific informed consent form prior to treatment.
Exclusion
- Evidence of distant metastases (below the clavicle) by clinical or radiographic examination.
- 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.
- Contraindications to general anesthesia.
- Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
- 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
- Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02225496
Start Date
September 23 2014
End Date
December 8 2017
Last Update
December 15 2017
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030