Active — Not RecruitingPhase 2

Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer

United States40 participantsStarted 2021-02-16

Plain-language summary

This study will enroll patients with HPV-associated oropharyngeal cancer, undergoing resection of all gross visible disease at the primary site and in the lymph nodes. A total of 40 patients who have had or will require surgery to remove cancer cells prior to starting chemoradiation may be enrolled. All eligible patients will receive de-intensified cisplatin-based chemoradiation, with high-risk patients receiving a higher dose and longer treatment period than other patients on the study. The study will assess whether a de-intensified version of standard chemoradiation treatment will be just as effective in treating HPV-associated oropharyngeal cancer while causing less side effects than standard dosing.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
✓. p16 should be strongly and diffusely positive in the nuclear and cytoplasmic component in greater than 70% of the tumor cells.
✓. 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.
✓. Have undergone or will undergo neck dissection.
✓. Have at least one of the following after surgery:
✓. Age ≥ 18 years old
✓. ECOG performance status 0 or 1 within 56 days of start of chemoradiation.

Exclusion criteria

What they're measuring

2-Year Progression-Free Survival (PFS)

Timeframe: 2 years

Trial details

NCT IDNCT04502407

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-15

View on ClinicalTrials.gov More HPV Positive Oropharyngeal Squamous Cell Carcinoma trials