Study on Swallowing Outcomes and Tumor DNA in Patients with HPV-Related Throat Cancer Treated with Surgery and Reduced Therapy
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT04920344
This clinical trial is exploring whether using lower doses of radiation and chemotherapy after surgery can improve the quality of life for patients with HPV-related throat cancer, without affecting their survival chances.
Patient Parameters
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Program Overview
This study is investigating if using lower doses of radiation and chemotherapy after surgery can help patients with HPV-related throat cancer have a better quality of life compared to the usual treatment. The trial will also look at how the cancer's DNA in the blood changes after surgery and how well the cancer is controlled over time.
Description
The main goal of this study is to see how well patients with HPV-related throat cancer can swallow and how their quality of life is affected after surgery and reduced therapy. The study will also look at changes in the cancer's DNA in the blood and how well the cancer is controlled over time.
Patients will be divided into three groups based on their cancer's risk level after surgery:
- Low Risk Group: Patients whose small tumor was completely removed and have only one affected lymph node will be monitored without further treatment.
- Medium Risk Group: Patients whose tumor was completely removed but have certain features that make it more likely to return will receive radiation therapy for 5 weeks.
- High Risk Group: Patients whose tumor could not be completely removed or has spread significantly will receive radiation therapy for 6 weeks and weekly chemotherapy.
After treatment, patients will be followed up for 3 years to monitor their health and cancer status.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with HPV-related throat cancer.
- Cancer stage T1-2, N0-N3, M0 according to specific medical criteria.
- Tumors must be removable with acceptable risk.
- Expected to live at least 12 more weeks.
- Must agree to participate and provide informed consent.
- Must be in relatively good health with a performance status of 3 or less.
- Detectable levels of HPV DNA in the blood.
- Adequate blood cell counts and organ function as determined by specific tests.
- Negative pregnancy test for women of childbearing age.
Exclusion Criteria
- Have not received previous treatment for their throat cancer, except for a biopsy.
- Have another primary cancer, unless treated and disease-free for at least 3 years.
- Cancer has spread beyond the neck.
- Serious health conditions that could affect safety or ability to complete the study.
- Under 18 years old.
- HIV-positive patients must meet specific health criteria.
- Severe electrolyte imbalances that cannot be corrected.
- Pregnant women or those not using effective contraception.
- Tumors that cannot be removed safely or are too large.
- Extensive spread of cancer outside the lymph nodes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick | 08903 | New Brunswick | New Jersey |
| Rutgers Cancer Institute of New Jersey at University Hospital | 07103 | Newark | New Jersey |
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