Actively Recruiting
Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
Led by Omar Mahmoud · Updated on 2025-05-22
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a lower intensity treatment approach for elderly patients with HPV-associated oropharynx cancer. This study aims to compare the effects of using lower dose radiation with smaller treatment fields combined with chemotherapy against the usual higher dose treatments. The purpose is to see if this new approach can maintain similar cancer control rates while reducing long-term side effects, which have been common with standard high-dose radiation and chemotherapy. About 30 participants will receive radiation therapy once daily, five days a week, totaling 55 Gy over five weeks, alongside weekly cisplatin chemotherapy infusions for five weeks. The radiation will be delivered using intensity modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) with smaller targeted fields. Chemotherapy infusions will last 30 to 60 minutes but may extend clinic time due to medications to prevent side effects. This regimen differs from the standard 69.96 Gy radiation over 6.5 weeks with chemotherapy. Participants will be monitored over two years to assess cancer progression-free survival, treatment benefits, tolerance, acute and late toxicities, and patterns of treatment failure. Assessments include medical exams, lab tests, and monitoring side effects. The study will help determine if the lower intensity treatment provides similar survival outcomes with fewer side effects. The study starts in May 2025 and lasts until September 2026.
CONDITIONS
Brief Title
Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Measurable disease at the primary site or nodal stations
- P16-positive by local immunohistochemical staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age 65 to 99 years
- Normal organ and marrow function within 14 days before registration defined as: absolute neutrophil count ≥ 1,500/mcL, platelets ≥ 100,000/mcL, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5× institutional upper limit of normal, AST or ALT ≤ 3.0× institutional upper limit, serum creatinine ≤ 1.5× institutional upper limit
You will not qualify if you...
- Metastatic disease
- Recurrent disease after primary management
- Cancers with center of mass outside oropharyngeal boundaries
- Synchronous double primaries
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
- Severe active comorbidity with life expectancy less than 1 year
- Autoimmune disease
- Uncontrolled HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive daily radiation therapy 5 days a week for 5 weeks and weekly chemotherapy with cisplatin administered through the vein for about 30-60 minutes each week during radiation treatment.
Daily visits for radiation therapy (5 days per week) and weekly visits for chemotherapy infusion
Trial Site Locations
Total: 1 location
1
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
Research Team
R
Regulatory Office
C
Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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