Clinical trial NCT06234748: Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer
Official title: Pilot Phase II Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Oropharynx Cancer
HPV-Related Carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients must have pathologically confirmed, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
* AJCC 8 Stage III (cT4 or N3)
* ECOG 0-1 performance status within two weeks of enrollment
* Pre-treatment laboratory criteria within four weeks of enrolment: WBC \> 3500/ul, granulocyte \> 1500/ul. Platelet count \> 100,000/ul. Total Bilirubin \< 1.5 X ULN. AST and ALT \< 2.5 X ULN. Estimated Creatinine clearance \>30cc/min
* Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist
* Age \>18
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.

Exclusion Criteria:

* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
* Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
* Patients should have no contraindications to having a contrast enhanced PET scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study;

Primary outcomes:
measure: Toxicity of treatment based off of Adverse Events collected per CTCAE v5.0
timeFrame: up to 3 years from start of treatment
Secondary outcomes:
measure: Tumor size of multi-imagine modality directed RT boost
timeFrame: 4 weeks after starting treatment
measure: Local regional recurrence free survival
timeFrame: up to 3 years from start of treatment
measure: Pattern of HPV ctDNA biomarkers in blood
timeFrame: baseline and surveillance, up to 24 months
measure: Pattern of HPV ctDNA biomarkers in urine
timeFrame: baseline, treatment, and surveillance, up to 24 months
measure: Oral microbiome analysis to compile biomarker information
timeFrame: pre and post treatment, up to 24 months
measure: Biomarker analysis from tumor tissue, to compile biomarker information
timeFrame: pretreatment and at 2 weeks
measure: MRIs and FDG PET scans- efficacy and toxicity
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Michelle Mierzwa
role: PRINCIPAL_INVESTIGATOR
References: