SIRS 2.0

The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)

Objective

The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA), either with transoral robotic surgery (TORS) alone or combined with reduced doses of radiation and chemotherapy can result in cancer control and survival comparable to those previously reported with standard therapy.

Study Arms

• Experimental: Robotic surgery only
• Experimental: Robotic surgery with de-intensified adjuvant therapy

Eligibility

• OPSCC with positive p16 immunohistochemistry and HR-HPV DNA or RNA PCR
• Detectable baseline cfHPVDNA (greater than or equal to 10 fragments/mL)
• Undetectable baseline cfHPVDNA (less than 5 fragments/mL)
• Early and intermediate stage (T1N0-2B, T2N0-2B) disease without evidence of distant metastases or gross extranodal extension
• Age > 18 years
• No previous surgery, radiation therapy, or chemotherapy for head and neck cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Less than or equal to 20 pack year tobacco history with no active tobacco use
• Adequate bone marrow, hepatic and renal functions
• Undetectable cfHPVDNA after surgery. Undetectable cfHPVDNA is defined as <5 fragments/mL

NCT ID

NCT05419089