Milder treatment after robotic surgery may cut side effects for HPV throat cancer patients
NCT ID NCT04502407
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a less intense version of standard chemo-radiation for people with HPV-positive throat cancer who have had robotic surgery to remove visible tumors. The goal is to see if the milder treatment works just as well as the standard dose but causes fewer side effects. About 40 participants will receive either a higher or lower dose of chemo-radiation based on their risk level.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx. 2. For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II. 3. p16 should be strongly and diffusely positive in the nuclear and cytoplasmic component in greater than 70% of the tumor cells. 4. Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with unknown primary tumors, a minimum of an ipsilateral tonsillectomy and base of tongue resection is required. 5. Have undergone or will undergo neck dissection. 6. Have at least one of the following after surgery: * Pathologic stage T3 * 2 or more positive lymph nodes * At least one lymph node \>3cm * Lymphovascular invasion * Perineural invasion * Extranodal extension * Close/positive margins: Close margins are considered \<3mm from the peripheral margins and \<1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma. 7. Age ≥ 18 years old 8. ECOG performance status 0 or 1 within 56 days of start of chemoradiation. 9. Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation. 10. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 11. Adequate hematologic and renal function within 30 days of start of chemoradiation, defined as: * Hemoglobin ≥ 9.0 g/dL * Platelets ≥ 100, 000 cells/mm3 * ANC ≥ 1.5 X 109/L * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase/alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN) * Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥60 mL/min Exclusion Criteria: 1. AJCC 8th edition pT4 or cN3 disease. 2. Radiologic or clinical evidence of distant metastasis. 3. Recurrent disease. 4. Inability to achieve gross total resection at time of surgery. 5. Greater than 56 days (8 weeks) after surgical resection of the primary site. 6. Prior radiation to the head and neck \> 30 Gy. 7. Prior active invasive (not in situ) malignancy within the prior 2 years, excluding cutaneous basal cell or squamous cell carcinoma, low or intermediate risk prostate cancer, papillary thyroid cancer, AJCC 8th edition stage I-II breast cancer, or low grade non-Hodgkin lymphoma 8. Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects * Uncontrolled Acquired Immune Deficiency Syndrome (AIDS), defined as a CD4 count \< 200 at screening or an AIDS-defining opportunistic infection within the last 6 months. 9. Moderate to severe hearing loss. 10. Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression. 11. Pregnant or breast-feeding women. 12. Prior allergic reaction to cisplatin. 13. Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center (Beverly - Main Site)
Los Angeles, California, 90048, United States
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Torrance Memorial Physician Network Cancer Care
Torrance, California, 90505, United States
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Tower Hematology-Oncology
Beverly Hills, California, 90211, United States
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Valley Oncology Medical Group
Tarzana, California, 91356, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a DNA vaccine boost immunotherapy against HPV-Linked head and neck cancer?
- Blood test may tailor throat cancer treatment, sparing patients from harsh side effects
- Robotic surgery may spare throat cancer patients from chemo and radiation
- Vaccine trains immune system to fight HPV-Positive head and neck tumors
- New Vaccine-Drug combo aims to tame HPV throat cancer with less radiation