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

NCT03729518 | Active Not Recruiting FDA Device

• 1 other identifier: UPCC 15318
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oropharyngeal Cancer; Squamous Cell Carcinoma; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 2-year locoregional control

  Number of patients with 2-year locoregional control, defined as control at the primary site and in the neck, in patients undergoing de-intensified radiation to the primary site and regional lymphatics after Transoral Robotic Surgery (TORS) and neck dissection for p16+ oropharyngeal squamous cell carcinoma (OPSCC)

  2 years

Secondary Outcomes (7)

• Treatment-related toxicity

  2 years

• 2-year progression-free survival

  3 years

• Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)

  1 year

• Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment

  2 years

• Metastasis-free survival

  3 years

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Radiation: Radiation Therapy (IMRT or IMPT)

Interventions

Radiation Therapy (IMRT or IMPT) RADIATION

* Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered. * Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist. * Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Oropharyngeal Neoplasms; Carcinoma, Squamous Cell

Interventions

Radiotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: October 11, 2018
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)