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8110 Gatehouse Road, Falls Church, VA 22042

Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing (EA3132)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT02734537

Background Information

This is a study to evaluate treatment after surgery for head and neck cancer. The purpose of this study is to compare two treatment approaches that are currently used after surgery for head and neck cancer. One approach is to administer radiation therapy alone. A second approach is to administer radiation therapy along with the chemotherapy drug, cisplatin. Cisplatin is approved by the United States Food and Drug Administration (FDA) to be used with radiation therapy for the treatment of head and neck cancer.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (AJCC 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
  • Participant has undergone total resection of the primary tumor with curative intent
  • Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer. Patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
  • Additional eligibility in protocol

Ineligibility Information

  • Positive HPV status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
  • Previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT02734537