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Trial Title:
Shortened Course Adjuvant Radiotherapy Following TORS
NCT ID:
NCT05714657
Condition:
HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Shortened Course Adjuvant Radiotherapy Following TORS
Description:
Shortened Course Adjuvant Radiotherapy Following TORS
Arm group label:
Shortened Course Adjuvant Radiotherapy
Summary:
This is a single-arm, phase II study to establish the safety of reducing radiation dose
in selected HPV-Associated 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 non-inferiority study of adjuvant radiation for
locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with
pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and
undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS
primary site resection and neck dissection. Patients will undergo adjuvant RT +/-
guideline-indicated chemotherapy. The neck and the primary site will be considered
separately.
The primary objective of the study will be to determine the 2-year locoregional control
(LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE,
version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire),
progression-free survival, metastasis-free survival, and overall survival. Differences
between patients treated with IMRT and proton therapy in terms of toxicity and QOL will
serve as another secondary objective.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients ≥ 18 years old
- Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx,
p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
- Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
- Pathologic N0-N1 disease (per AJCC 8th Ed)
- Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
- Undetectable postoperative plasma ctHPVDNA
- ECOG Performance Status 0-1
Exclusion Criteria:
- Prior external beam radiation therapy to the head and neck
- Presence of T4 disease
- ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lancaster General Hospital
Address:
City:
Lancaster
Zip:
17604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alyson Eckert, RN
Phone:
717-544-0511
Email:
Alyson.Eckert@pennmedicine.upenn.edu
Investigator:
Last name:
Pamela Boimel, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Project Manager
Email:
RadOncCRU@PennMedicine.upenn.edu
Contact backup:
Last name:
Lin
Investigator:
Last name:
Alexander Lin, MD
Email:
Principal Investigator
Facility:
Name:
Pennsylvania Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Project Manager
Email:
RadOncCRU@PennMedicine.upenn.edu
Start date:
January 30, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714657
