NCT06309225Recruiting
Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Omar Mahmoud
- Diseases
- Head and neck cancer
- NCT number
- NCT06309225
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 15 Dec 2025 to the primary completion date, 30 Sept 2027
- 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
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
Other illness
- Metastatic disease
- Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
- Autoimmune disease
- Uncontrolled HIV
Other
- Synchronous double primaries
- Severe active comorbidity where life expectancy is \<1 year.
Who the study is looking for
- 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
Age in the registry: 65 years to 99 years · 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 |
|---|---|---|---|
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.