Monday, October 26, 2026 · Daily editionET --:--:--

Finished

The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL)

NCT02072148 · Icahn School of Medicine at Mount Sinai · Updated 6 May 2024

What is being tested
PET/CT; Radiotherapy; Concurrent Chemoradiation; Concurrent Chemoradiation
For
Human Papilloma Virus; Oropharyngeal Squamous Cell Carcinoma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 112 people. The full rules are on the registry page.
Where
United States (2 sites)
When
Starts or started March 2014, ends 12 May 2022. Registered 26 Feb 2014.
Results
Posted on the registry on 6 May 2024.

In the researchers' words

In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients. Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis…
ClinicalTrials.gov, NCT02072148

Sites

  • Mount Sinai Beth IsraelNew York, New York, United States
  • Icahn School of Medicine at Mount SinaiNew York, New York, United States