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

  • End date
    Oct 11, 2024
  • participants needed
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 18 December 2021
squamous cell carcinoma
primary tumor
chemotherapy regimen
intensity-modulated radiation therapy
oropharyngeal carcinoma
oropharyngeal squamous cell carcinoma


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.


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.

Condition Oropharyngeal Cancer, Squamous Cell Carcinoma, Human Papilloma Virus
Treatment Radiation Therapy (IMRT or IMPT)
Clinical Study IdentifierNCT03729518
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on18 December 2021


Yes No Not Sure

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
Clear my responses

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