Philadelphia, Pennsylvania 19104


Purpose:

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.


Study summary:

This is a single arm Phase II study of adjuvant radiation for locally-advanced p16+ oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N2b, M0 disease (per AJCC 7th ed) with <5 positive lymph nodes, will be eligible. Patients will have undergone TORS primary site resection and ipsilateral neck dissection. Patients will undergo radiation dose reduction and target volume reduction.


Criteria:

Inclusion Criteria: - Patients >= 18 years old - Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry - Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed) - Pathologic N0, N1, N2a, or N2b disease (per AJCC 7th Ed), with < 5 positive lymph nodes - ECOG Performance Status 0-1 Exclusion Criteria: - Prior radiation therapy to the head and neck - Presence of T4 disease - Presence of N2c or N3 neck disease (per AJCC 7th Ed) - >= 5 lymph nodes - Presence of distant metastatic disease


NCT ID:

NCT03729518


Primary Contact:

J. Nicholas Lukens, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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