Back to resultsTORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
Primary Purpose
Oropharyngeal Cancer, Squamous Cell Carcinoma, Human Papilloma Virus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy (IMRT or IMPT)
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Cancer
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Treatment-related toxicity
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-year progression-free survival
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)
Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)
Differences in toxicity outcomes in patients treated with IMRT versus proton therapy
Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment
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
Number of participants with metastasis-free survival
Patient reported quality of life outcomes
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
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)
Full Information
NCT ID
NCT03729518
First Posted
October 29, 2018
Last Updated
December 15, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03729518
Brief Title
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
October 11, 2024 (Anticipated)
Study Completion Date
October 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer, Squamous Cell Carcinoma, Human Papilloma Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy (IMRT or IMPT)
Intervention Description
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 Outcome Measure Information:
Title
2-year locoregional control
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment-related toxicity
Description
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)
Time Frame
2 years
Title
2-year progression-free survival
Description
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)
Time Frame
3 years
Title
Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)
Description
Differences in toxicity outcomes in patients treated with IMRT versus proton therapy
Time Frame
1 year
Title
Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment
Description
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.
Time Frame
2 years
Title
Metastasis-free survival
Description
Number of participants with metastasis-free survival
Time Frame
3 years
Title
Patient reported quality of life outcomes
Description
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.
Time Frame
2.5 years
Title
Overall survival
Description
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)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
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