NCT06234748Active, not recruitingPhase 2
Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer
Pilot Phase II Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 20 Dec 2023
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06234748
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 19
- From 20 Dec 2023 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study;
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.