Lower dose chemoradiotherapy for elderly patients with HPV-associated oropharynx cancer
Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)
This study is testing a lower dose of radiation and chemotherapy to see if it can help older patients with HPV-related throat cancer while causing fewer side effects than the usual higher doses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 99 Years |
| Sex | All |
| Sponsor | Baptist MD Anderson Cancer Center, Florida Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy, radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06309225 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a modified regimen of lower dose radiation therapy and chemotherapy in elderly patients diagnosed with HPV-associated oropharynx cancer. Participants will receive radiation therapy once daily for five weeks, totaling 55 Gy, along with weekly cisplatin chemotherapy. The goal is to compare the outcomes of this less intensive treatment approach to standard higher dose regimens, focusing on both efficacy and side effects. By evaluating the results, researchers aim to determine if this new approach can maintain similar survival rates while reducing treatment-related complications.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with a confirmed diagnosis of squamous cell carcinoma of the oropharynx who are P16-positive and have measurable disease.
Not a fit: Patients with metastatic disease, recurrent cancer, or those who have received prior radiation therapy for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer treatment option for elderly patients with oropharynx cancer, minimizing side effects while maintaining effective cancer control.
How similar studies have performed: Previous studies have indicated that lower dose radiation can achieve comparable cancer control rates with fewer side effects, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Regulatory Office
- Email: RegBMDA@bmcjax.com
- Phone: 904-202-7300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.