This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Patients will undergo 2 phases of RT replanning: 1. Based on 2-week DCE-MRI low BV tumor subvolume, patients will have a PTVboost1 that will start to receive 2.5Gy/day with fraction 16. PTVboost1=(persistent lowBVsubvolume\_2 wks+ MTV3\_2 weeks)+ 3mm margin. 2. Based on 4-week FDG-PET MTV3, patients with have a PTVboost2 cone down that will receive 2.5Gy/day starting with fraction 23. PTVboost2=(LBV\_2 wks + MTV3\_4wks)+ 3mm margin 3. Thus, the tumor subvolumes that are included in the boost from fx16-35 will receive 86 Gy EQD2 (80Gy physical dose) and the FDG-avid subvolumes which start boost at 2 weeks but are not persistently avid at 4 wks will receive 76Gy EQD2 (74Gy physical dose).
Standard of care therapy, weekly, with either Cisplatin or Carboplatin
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Toxicity of treatment based off of Adverse Events collected per CTCAE v5.0
The study team will calculate rates of in-field RT related toxicities including Grade 4+ and Grade 3+ with associated confidence intervals including dysphagia, mucositis, oral pain and oral bleeding events.
Time frame: up to 3 years from start of treatment
Tumor size of multi-imagine modality directed RT boost
The volume of tumor to be boosted will be calculated for each patient and summarized. Both physiologic MRI and FDG-PET will be used
Time frame: 4 weeks after starting treatment
Local regional recurrence free survival
The study team will summarize the number of patients with recurrence free survival
Time frame: up to 3 years from start of treatment
Pattern of HPV ctDNA biomarkers in blood
The study team will summarize the distribution of candidate biomarkers descriptively at each timepoint and also summarize longitudinal change graphically.
Time frame: baseline and surveillance, up to 24 months
Pattern of HPV ctDNA biomarkers in urine
The study team will summarize the distribution of candidate biomarkers descriptively at each timepoint and also summarize longitudinal change graphically.
Time frame: baseline, treatment, and surveillance, up to 24 months
Oral microbiome analysis to compile biomarker information
The study team will summarize the distribution of candidate biomarkers descriptively at each timepoint and also summarize longitudinal change graphically.
Time frame: pre and post treatment, up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Biomarker analysis from tumor tissue, to compile biomarker information
The study team will summarize the distribution of candidate biomarkers descriptively at each timepoint and also summarize longitudinal change graphically.
Time frame: pretreatment and at 2 weeks
MRIs and FDG PET scans- efficacy and toxicity
Pre- and mid treatment MRI and PET imaging metrics in the tumor will be correlated with 2 year PFS
Time frame: up to 2 years