NCT06309225 Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
| NCT ID | NCT06309225 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Omar Mahmoud |
| Condition | Oropharynx Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls) * Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. * P16-positive based on local site immunohistochemical tissue staining * Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.) * Age ≥ 65. * Normal organ and marrow function within 14 days prior to registration defined as follows: * Absolute neutrophil count ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN) * AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN * Serum creatinine ≤ 1.5× ULN Exclusion Criteria: * Metastatic disease * Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries * Synchronous double primaries * Prior radiotherapy for lymphoma or other malignancy * Prior systemic therapy including immunotherapy * Severe active comorbidity where life expectancy is \<1 year. * Autoimmune disease * Uncontrolled HIV
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06309225 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 99 Years, studying Oropharynx Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309225 currently recruiting?
Yes, NCT06309225 is actively recruiting participants. Contact the research team at RegBMDA@bmcjax.com for enrollment information.
Where is the NCT06309225 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06309225 clinical trial?
NCT06309225 is sponsored by Omar Mahmoud. The trial plans to enroll 20 participants.
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