Henry Ford Hospital has joined a national clinical trial to study the effectiveness of a newer robotic cancer surgery in treating patients with advanced-stage oropharyngeal cancer, a cancer that affects part of the throat, base of tongue, tonsils, soft palate (back of the mouth), and the walls of the pharynx (throat).
NRG Oncology-led study will compare survival and disease progression in patients who receive radiation and chemotherapy following TransOral Robotic Surgery (TORS) – which uses the da Vinci® Surgical System to access tumors through the mouth without an incision – versus those who are only treated with radiation and chemotherapy.
The study also will examine the safety and efficacy of TORS, as well as patient quality of life following treatment.
Henry Ford, the only site in Michigan participating in this national trial, is currently recruiting patients for the clinical trial with early- or late-stage HPV-negative oropharanygeal cancer to be treated with the TORS procedure.
TORS was approved in January 2010 by the U.S. Food and Drug Administration to remove malignant and benign tumors of the mouth, tongue, tonsils, and parts of the throat.
With TORS, surgeons can access tumors through the mouth using the slender operating arms of the da Vinci, thus not requiring an open skin incision.
“Prior to TORS, patients would traditionally begin treatment with radiation therapy, or a combination of chemotherapy and radiation therapy, depending on the stage of their cancer,” says the Henry Ford lead investigator Tamer Ghanem, M.D., Ph.D., director of Head and Neck Oncology and Reconstructive Surgery Division in the Department of Otolaryngology-Head & Neck Surgery at Henry Ford Hospital.
“It’s important for us to further study the effectiveness and safety of TORS, to provide our patients with the best treatment options for their head and neck cancer diagnoses.”
Dr. Ghanem is conducting the study at Henry Ford in collaboration with colleagues Francis Hall, M.D., and Steven Chang, M.D., both surgeons in the Henry Ford Department of Otolaryngology- Head & Neck Surgery.
Henry Ford is seeking patients, ages 18 and older, who have been diagnosed with clinical cell carcinoma of the oropharynx, localized to the tonsil, glossopharyngeal sulcus, and tongue-base within six weeks of registration.
The patient’s tumor must be HPV-negative.
For patients to participate, their primary tumor must be able to be removed through a transoral endoscopic head and neck surgery with anticipation of resection free margins. Specifically, patients must be able to completely open their mouth and cannot have poor transoral exposure of the tumor itself or surrounding soft-tissue margins.
Within 30 days prior to study registration, patients must have/undergo:
- A medical history and physical examination by the treating physician (radiation oncologist, medical oncologist, or head and neck surgeon)
- Imaging of the head and neck (CT with contrast, PET/CT and/or MRI) within 30 days prior to registration; a CT scan with contrast is mandatory; a PET/CT scan alone (unless performed with contrast) is not sufficient
- Chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast)
- Modified barium swallow to assess swallowing function
- Preoperative Mallampati assessment as documented by attending surgeon
- Women of childbearing potential and male participants who are sexually active must practice medically effective contraception during treatment and 42 days following completion of treatment. Patient must be able to provide study-specific informed consent prior to study entry.
This study, RTOG 1221, is sponsored by NRG Oncology and the National Cancer Institute.
For more information about the study including the complete patient eligibility criteria, visit www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1221.
To enroll, prospective participants should call (313) 916-9826.
To learn more about TORS at Henry Ford, go to www.henryford.com/ENT