NCT02072148

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied. There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.

Conditions

• Human Papilloma Virus
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	PET/CT	PET scan or CT scan q 4 months for 5 years
RADIATION	Radiotherapy	Postoperative XRT 5000 cGy
RADIATION	Concurrent Chemoradiation	CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 5000 cGy
RADIATION	Concurrent Chemoradiation	CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 5600 cGy

Timeline

• Start date: 2014-03-01
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2014-02-26
• Last updated: 2024-05-06
• Results posted: 2024-05-06

Locations

2 sites across 1 country: United States