Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma

Korábbi kezelés

• Inability to complete full course of radiation treatment or attend follow-up visits.
• History of previous head and neck radiation or previous head and neck cancer within 3 years.

Más betegség

• Serious medical condition preventing general anesthesia for surgery.
• Distant metastatic disease present.
• Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.

Egyéb

• Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test within 60 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless the patients meet one of the following criteria:
  • Has undergone a hysterectomy or bilateral oophorectomy; or
  • Has been naturally amenorrheic for at least 24 consecutive months.

• Subjects ≥ 18 years old at the time of informed consent.
• Ability to provide written informed consent and HIPAA authorization.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (refer to Appendix).
• Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
• Histopathologically confirmed squamous cell carcinoma.
• HPV+ tumor, as determined by p16, in-situ hybridization, or real-time polymerase chain reaction.
  • Note: If patients present who have unconfirmed p16/HPV positive disease but have clinical findings that indicate a high probability of HPV positive disease, these patients can be deemed eligible after testing is performed at post-surgery.
• Resectable and accessible tumor with high probability of achieving negative margins.
• Smokers and non-smokers included.
• Tumor stage (AJCC 8th edition): T1 or T2.
• Nodal stage (AJCC 8th edition): N0, N1 or N2.
• Mobile neck nodes on physical exam if N positive.
• Subjects with synchronous primaries included.
• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.