Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

Stopped early · Phase 2

Conditions studied: Oropharyngeal Cancer

In brief

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.

Key facts

Study ID

NCT02225496

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2014-09-23

Expected to finish

2017-12-08

Last updated by the study team

2017-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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