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Completed

NCT Number: NCT03729518

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

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.

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Key information

Conditions

Oropharyngeal Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Human Papilloma Virus Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Squamous Cell Carcinoma Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 2-year locoregional control

    Time frame: 2 years

    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)

Secondary outcomes

  1. Treatment-related toxicity

    Time frame: 2 years

    Number of participants with treatment-related toxicity as gauged by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. the CTCAE v.5 utilizes a five point scale to report Adverse Events (AEs), defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure (cancer.gov)

  2. 2-year progression-free survival

    Time frame: 3 years

    Number of participants with 2-year progression-free survival, defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse (nih.gov)

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

    Time frame: 1 year

    Differences in toxicity outcomes in patients treated with IMRT versus proton therapy

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

    Time frame: 2 years

    Number of patients with a change in circulating HPV cells during the course of treatment, determined using a next generation sequencing (NGS) assay developed to detect HPV DNA in HPV+ oropharyngeal squamous cell carcinoma patients.

  5. Metastasis-free survival

    Time frame: 3 years

    Number of participants with metastasis-free survival

  6. Patient reported quality of life outcomes

    Time frame: 2.5 years

    Patient reported quality of life (QOL) outcomes using MD Anderson Symptom Inventory (MDASI) Head and Neck survey between patients treated with IMRT and IMPT. The MDASI-HN assesses the severity of symptoms in the last 24 hours using a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine". The interference of symptoms in the last 24 hours is assessed using a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely". The mean of symptom severity and interference can be used to represent overall symptom distress and can be analyzed for changes over treatment and during follow-up.

  7. Overall survival

    Time frame: 5 years

    Number of patients with overall survival, as defined by the length of time from the date of diagnosis or start of treatment for a disease that patients diagnosed with the disease are still alive (cancer.gov)

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 2, 2018
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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