TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

Completed · Not applicable

Conditions studied: Oropharyngeal Cancer, Squamous Cell Carcinoma, Human Papilloma Virus

In brief

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.

Key facts

Study ID

NCT03729518

Run by

Abramson Cancer Center at Penn Medicine

People needed

150

Starts

2018-10-11

Expected to finish

2026-07-15

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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