Study on Using Circulating Tumor DNA to Adjust Post-Surgery Treatment for HPV-Related Throat Cancer
Sponsor: Zachary Zumsteg
ClinicalTrials ID:NCT06445114
This clinical trial is exploring a new approach to tailor post-surgery treatment for patients with HPV-related throat cancer by using circulating tumor DNA to assess risk and guide therapy decisions.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is being conducted at a single institution and involves patients with certain types of HPV-related throat cancer who have undergone surgery to remove visible tumors. The goal is to use circulating tumor DNA (cTTMV-HPV DNA) to determine the best post-surgery treatment plan, which includes a less intense chemotherapy and radiation regimen. The treatment will be adjusted based on the DNA results and other factors from the surgery.
Description
All eligible patients will receive a reduced-intensity treatment with the chemotherapy drug cisplatin, given alongside radiation therapy, after having surgery to remove the cancer. The treatment plan will be personalized based on the levels of circulating tumor DNA and the characteristics of the cancer found during surgery. Patients will receive weekly doses of cisplatin through an IV, along with radiation therapy targeted at the primary tumor site and nearby lymph nodes. Depending on their risk level, some patients may receive additional radiation doses. If a patient cannot tolerate the standard dose of cisplatin, an alternative treatment will be provided.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of HPV-related throat cancer, including cancer of the tonsils, base of the tongue, and other areas in the throat.
- Must have had or will have surgery to remove all visible cancer in the head and neck.
- Must have certain cancer characteristics after surgery, such as larger tumors or cancer spread to multiple lymph nodes.
- Must have detectable HPV DNA in the blood or tumor tissue.
- Be 18 years or older.
- Be in good overall health with a performance status score of 0 or 2.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must have adequate blood and kidney function as shown by specific lab tests.
- Must be able to understand and agree to the study requirements.
Exclusion Criteria
- Have a more advanced stage of throat cancer than specified.
- Have cancer that has spread to distant parts of the body.
- Have recurrent cancer.
- Unable to have all visible cancer removed during surgery.
- More than 8 weeks have passed since surgery.
- Have had previous radiation to the head and neck above a certain dose.
- Have had another active invasive cancer within the past 2 years, with some exceptions.
- Have severe heart problems or infections requiring hospitalization in the past 6 months.
- Have moderate to severe hearing loss.
- Have active autoimmune diseases requiring treatment.
- Are pregnant or breastfeeding.
- Have had an allergic reaction to cisplatin.
- Have received live vaccines within 30 days before starting treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Cancer at Beverly Hills (THO) | 90211 | Beverly Hills | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| CS Cancer at Valley Oncology Medical Group | 91356 | Tarzana | California |
| CS Cancer at the Hunt Cancer Center | 90505 | Torrance | California |
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