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

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

The hope is that with this newer approach, the long-term complications from chemotherapy and radiation can be reduced.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• OPSCC with positive p16 immunohistochemistry and HR-HPV DNA or RNA PCR

• Detectable baseline cfHPVDNA (greater than or equal to 10 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

Exclusion Criteria:

• Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, supraclavicular or matted metastatic disease, >3 radiographic pathologic cervical nodes

• Previous or current malignancies at other locations, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery/radiotherapy, ductal carcinoma in situ of the breast treated with surgery/radiotherapy, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.

• Non-high-risk HPV subtype on initial biopsy or final pathology

• presence of 5 or more positive nodes, irrespective of size, on final pathology

• p16 negative or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.

• Undetectable or < 10 copies/mL baseline cfHPVDNA prior to surgery

• Autoimmune disease treated with chemotherapy agents, anti TNF agents, or hydroxychloroquine within the last 5 years

• Other serious illnesses or medical conditions

• Participation in an investigational therapeutic drug trial within 30 days of study entry