Study on Reduced Radiation and Standard Chemotherapy for HPV-Positive Throat Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05491512
This clinical trial is exploring whether using lower doses of radiation, along with standard chemotherapy, can help reduce side effects in people with HPV-positive throat cancer. The chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil (5-FU), paclitaxel, and Abraxane.
Patient Parameters
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Program Overview
The aim of this study is to determine if reducing the amount of radiation therapy, when combined with standard chemotherapy, can lessen the side effects for patients with HPV-positive throat cancer. The chemotherapy drugs used in this study are cisplatin, carboplatin, 5-fluorouracil (5-FU), paclitaxel, and Abraxane (Albumin-bound Paclitaxel).
Eligibility Criteria
Inclusion Criteria
- Diagnosed with HPV-related squamous cell carcinoma of the throat (tonsil, base of tongue, or throat walls) through biopsy or surgery.
- Cancer of unknown origin in the neck is allowed if a lymph node biopsy is done.
- Must have visible cancer at the primary site or lymph nodes.
- No signs of cancer spread to distant parts of the body.
- Must have a CT or MRI scan of the neck.
- Performance status score of 0-2 or KPS score of 50 or higher.
- Age 18 or older (patients over 70 can enroll in a specific group).
- Adequate blood cell counts and organ function based on recent tests.
- Women of childbearing potential must have a negative pregnancy test.
- Must provide informed consent and be able to undergo MRI scans unless medically exempt.
Exclusion Criteria
- Previous radiation therapy to the head and neck.
- Having another primary cancer outside the throat area, unless approved by the study leaders.
- History of invasive cancer unless disease-free for 3 years or with a high cure rate.
- Previous chemotherapy for the throat cancer being studied (chemotherapy for other cancers is allowed).
- Severe active health issues, such as:
- Recent unstable heart conditions or heart attack.
- Active infections needing IV antibiotics.
- Severe lung disease requiring hospitalization.
- Liver problems causing jaundice or blood clotting issues.
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