The study will compare the effectiveness of lose-dose and standard-dose radiation in patients who undergo TransOral Robotic Surgery (TORS) – which uses the da Vinci® Surgical System to access tumors through the mouth without an incision – for removal of their tumor.
Henry Ford Hospital, a member of ECOG-ACRIN and the first site in Michigan participating in this national multi-site trial, is currently recruiting patients with stage 3 or stage 4 HPV-positive oropharyngeal cancer to be treated with the TORS procedure, followed by radiation therapy and possibly chemotherapy.
Oropharyngeal cancer affects part of the throat, base of tongue, tonsils, soft palate (back of the mouth), and the walls of the pharynx (throat). The American Cancer Society estimates that in 2014 about 37,000 Americans will get oral cavity or oropharyngeal cancer and roughly 7,300 people will die of these cancers.
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.
“Prescribing radiation therapy and chemotherapy may kill any tumor cells that remain after surgery,” says 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.
"The aim of the study is to reduce the amount of postoperative radiation to decrease the toxicity to the patients who fit certain criteria based on their surgical findings."
Dr. Ghanem is leading the study at Henry Ford in collaboration with colleagues Francis Hall, M.D., and Steven Chang, M.D., both surgeons in the Department of Otolaryngology- Head & Neck Surgery at Henry Ford.
The study was designed and is being conducted by ECOG-ACRIN under the sponsorship of the National Cancer Institute.
The clinical trial includes four study arms:• Arm A: Patients undergo TORS for the removal of their oropharyngeal tumor• Arm B: Patients undergo TORS for the removal of their oropharyngeal tumor, followed by low-dose radiation therapy five days a week for five weeks• Arm C: Patients undergo TORS for the removal of their oropharyngeal tumor, followed by standard-dose radiation therapy five days a week for six weeks• Arm D: Patients undergo TORS for the removal of their oropharyngeal tumor, followed by standard-dose radiation therapy five days a week for six to seven weeks. Patients in this arm also receive the chemotherapy.
Patients are placed into Arms A and D based on their cancer pathology (diagnosis, tumor size, tumor margins, etc.); patients are randomly selected for Arms B and C.
Study participantsFor the study, the Henry Ford Hospital is seeking patients, 18 years or older, who have been newly diagnosed with clinical stage 3 or stage 4 squamous cell carcinoma of the oropharynx that is HPV-positive.
To participate, patients:• Must have a complete head and neck exam and CT scan (with contrast) or MRI.• Cannot have an illness likely to interfere with protocol therapy or surgery for the clinical trial, or uncontrolled diabetes, infection or hypertension within 30 days prior to registration.• May not be pregnant or breastfeeding; all women of childbearing potential must have a blood or urine test within two weeks prior to registration to rule out pregnancy.• Must use contraceptives if they are sexually active or of child-bearing potential.
For more information about the study, visit http://clinicaltrials.gov. To enroll, prospective participants should call (313) 916-9826.
To learn more about TORS at Henry Ford, go to www.henryford.com/ENT.
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