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

Not Applicable

Active, not recruiting

• Conditions: Human Papilloma Virus; Squamous Cell Carcinoma; Oropharyngeal Cancer
• Interventions: Radiation: Radiation Therapy (IMRT or IMPT)

• Registration Number: NCT03729518
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-11
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Radiation Therapy (IMRT or IMPT)	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.

Primary Outcome Measures

Name	Time	Method
2-year locoregional control	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 Outcome Measures

Name	Time	Method
Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment	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.
Metastasis-free survival	3 years	Number of participants with metastasis-free survival
Patient reported quality of life outcomes	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.
Overall survival	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)
Treatment-related toxicity	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)
Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)	1 year	Differences in toxicity outcomes in patients treated with IMRT versus proton therapy
2-year progression-free survival	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)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States