The Sinai Robotic Surgery Trial for HPV-related Throat Cancer (SIRS 2.0 Trial)
Sponsor: Icahn School of Medicine at Mount Sinai
ClinicalTrials ID:NCT05419089
This study is exploring whether robotic surgery alone can effectively control HPV-related throat cancer in patients who have no detectable HPV tumor DNA in their blood after surgery. The aim is to reduce long-term side effects from chemotherapy and radiation.
Patient Parameters
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Program Overview
The study is investigating if using robotic surgery alone can control HPV-related throat cancer as effectively as standard treatments, in patients who have no detectable HPV tumor DNA in their blood after surgery. This approach hopes to minimize the long-term side effects associated with chemotherapy and radiation.
Description
Throat cancer cases have been rising in North America and Europe, with HPV-related throat cancer now making up over 80% of these cases in the USA. HPV-related throat cancer generally has a good outlook, especially in intermediate stages, which raises questions about the need for aggressive treatments like chemotherapy and radiation. These treatments can have significant long-term side effects.
A new blood test that measures HPV tumor DNA has shown promise in monitoring treatment response and checking for cancer recurrence. A negative test result after treatment is a strong indicator that the cancer has not returned.
In this trial, patients with HPV-related throat cancer will be grouped based on their risk level after robotic surgery. Those with low or intermediate risk and no detectable HPV tumor DNA in their blood after surgery will not receive additional therapy. Eligible patients must have early to intermediate stage cancer, with specific criteria regarding tumor size and spread, and must not be active smokers or have a significant smoking history.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed HPV-related throat cancer that can be surgically removed, with specific test results showing HPV presence.
- Must have detectable HPV tumor DNA in the blood before surgery and undetectable levels after surgery.
- Cancer must be in early to intermediate stages, without distant spread or significant lymph node involvement.
- Must be 18 years or older.
- No previous major treatments for head and neck cancer, except minor surgeries.
- Must be in good general health, with a performance status of 0 or 1.
- No active smoking or significant smoking history.
- Must be able to understand and sign a consent form.
- Must have adequate blood, liver, and kidney function.
Exclusion Criteria
- Under 18 years old.
- Pregnant or breastfeeding.
- Other active or recent cancers, except for certain treated cases.
- Serious medical conditions, including heart disease, neurological disorders, infections, or substance abuse.
- Previous organ transplant or certain lung diseases.
- Participation in other cancer treatment trials recently.
- Advanced cancer stages or types not related to HPV.
- Autoimmune diseases treated with specific medications recently.
- Detectable HPV tumor DNA in the blood after surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Valley - Mount Sinai Comprehensive Cancer Care | 07652 | Paramus | New Jersey |
| Mount Sinai Health System | 10019 | New York | New York |
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