Actively Recruiting
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
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less. For this reason this study is looking at a different regimen of reducing the intensity of the treatment. The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
CONDITIONS
Official Title
Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Clinically or radiographically measurable disease at the primary site or nodal stations
- P16-positive based on local immunohistochemical tissue staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age 65 or older
- Normal organ and marrow function within 14 days prior to registration defined as:
- Absolute neutrophil count 1500/mcL or higher
- Platelets 100,000/mcL or higher
- Hemoglobin 8.0 g/dL or higher
- Total bilirubin 1.5 times or less the institutional upper limit of normal
- AST(SGOT) or ALT(SGPT) 3.0 times or less the institutional upper limit of normal
- Serum creatinine 1.5 times or less the institutional upper limit of normal
You will not qualify if you...
- Metastatic disease
- Recurrent disease after primary management
- Cancers with center of mass outside the oropharyngeal boundaries
- Synchronous double primary cancers
- 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
Trial Site Locations
Total: 1 location
1
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
Research Team
R
Regulatory Office
CONTACT
C
Clinical Trials Office
CONTACT
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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