Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Trial Title: Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

NCT ID: NCT06234748

Condition: Oropharynx Cancer
HPV-Related Carcinoma

Conditions: Official terms:
Oropharyngeal Neoplasms
Cisplatin
Carboplatin

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: Radiation
Description: 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).
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Platinum based chemotherapy
Description: Standard of care therapy, weekly, with either Cisplatin or Carboplatin
Arm group label: Treatment Arm

Other name: Cisplatin

Other name: Carboplatin

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.

Criteria for 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;

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Michigan Rogel Cancer Center

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Status: Recruiting

Contact:
Last name: Michelle Mierzwa, M.D.

Phone: 734-936-7810
Email: mmierzwa@med.umich.edu

Start date: December 20, 2023

Completion date: July 2026

Lead sponsor:
Agency: University of Michigan Rogel Cancer Center
Agency class: Other

Source: University of Michigan Rogel Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06234748