Back to resultsShortened Course Adjuvant Radiotherapy Following TORS
Primary Purpose
Oropharyngeal Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adjuvant radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Squamous Cell Carcinoma
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, N2b, or N2c disease (per AJCC 7th Ed), with < 5 positive lymph nodes Detectable preoperative plasma ctHPVDNA (copy number of > 200 copies/mL) Undetectable postoperative plasma ctHPVDNA ECOG Performance Status 0-1 Exclusion Criteria: Prior radiation therapy to the head and neck Presence of T4 disease Presence of N3 neck disease (per AJCC 7th Ed.) ≥ 5 positive lymph nodes Presence of distant metastatic disease Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Sites / Locations
- Abramson Cancer Center of the University of PennsylvaniaRecruiting
- University of PennsylvaniaRecruiting
- Pennsylvania HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy
Arm Description
The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol.1 In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.
Outcomes
Primary Outcome Measures
Locoregional control
To determine whether disease recurs locally (at primary site) or in the regionally in the nodes of the neck
Secondary Outcome Measures
Progression free survival
To determine progression free survival (any progression)
Metastasis free survival
To determine metastasis free survival (any distant metastasis)
Overall survival
To determine overall survival (alive or not)
Dysphagia, as measured by patient-reported outcome
To determine patient-reported quality of life (dysphagia) after completion of treatment, as assessed by the MDADI validated questionnaire
Quality of life, as measured by patient-reported outcome
To determine patient-reported quality of life (symptoms) after completion of treatment, as assessed by the MDASI-HN validated questionnaire
Full Information
NCT ID
NCT05714657
First Posted
August 3, 2022
Last Updated
June 22, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05714657
Brief Title
Shortened Course Adjuvant Radiotherapy Following TORS
Official Title
A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (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
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected p16+ OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
Detailed Description
This is a single-arm, phase II study of dose-reduced, adjuvant radiotherapy (10 treatments over 2 weeks) for patients with p16+ oropharyngeal squamous cell carcinoma after completion of transoral robotic resection (TORS) and selective neck dissection (SND). Selected patients will be required to have measurable preoperative circulating tumor human papillomavirus DNA (ctHPVDNA) and undetectable postoperative (pre-radiotherapy) ctHPVDNA. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group (AVOID trial, Swisher-McClure et al. 2020) and found to be safe and effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week).
Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol.1 In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.
Intervention Type
Radiation
Intervention Name(s)
adjuvant radiotherapy
Intervention Description
Shortened Course Adjuvant Radiotherapy Following TORS
Primary Outcome Measure Information:
Title
Locoregional control
Description
To determine whether disease recurs locally (at primary site) or in the regionally in the nodes of the neck
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival
Description
To determine progression free survival (any progression)
Time Frame
2 Years
Title
Metastasis free survival
Description
To determine metastasis free survival (any distant metastasis)
Time Frame
2 years
Title
Overall survival
Description
To determine overall survival (alive or not)
Time Frame
2 years
Title
Dysphagia, as measured by patient-reported outcome
Description
To determine patient-reported quality of life (dysphagia) after completion of treatment, as assessed by the MDADI validated questionnaire
Time Frame
2 years
Title
Quality of life, as measured by patient-reported outcome
Description
To determine patient-reported quality of life (symptoms) after completion of treatment, as assessed by the MDASI-HN validated questionnaire
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 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, N2b, or N2c disease (per AJCC 7th Ed), with < 5 positive lymph nodes
Detectable preoperative plasma ctHPVDNA (copy number of > 200 copies/mL)
Undetectable postoperative plasma ctHPVDNA
ECOG Performance Status 0-1
Exclusion Criteria:
Prior radiation therapy to the head and neck
Presence of T4 disease
Presence of N3 neck disease (per AJCC 7th Ed.)
≥ 5 positive lymph nodes
Presence of distant metastatic disease
Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Lin, MD
Phone
2156623198
Email
Alexander.Lin2@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wencesley Paez, MD
Phone
2156146086
Email
Wencesley.Paez@Pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Lin, MD
Organizational Affiliation
Abramson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Lin, MD
Phone
855-216-0098
Email
PennCancerTrials@emergingmed.com
First Name & Middle Initial & Last Name & Degree
Lin
First Name & Middle Initial & Last Name & Degree
Alexander Lin, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Lin, MD
Phone
855-216-0098
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Gentile, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Shortened Course Adjuvant Radiotherapy Following TORS
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