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

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Squamous Cell Carcinoma; Oropharyngeal Cancer; Human Papilloma Virus

Treatments: Radiation: Radiation Therapy (IMRT or IMPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03729518

UPCC 15318

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Arm 1

Experimental group

Description:

All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.

Treatment:

Radiation: Radiation Therapy (IMRT or IMPT)