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NCT06309225From ClinicalTrials.govRecruiting

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)

  • Oropharynx Cancer
  • Frailty

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Omar Mahmoud
Enrolment target
20
Started
15 December 2025
Main results due
30 September 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 65 years to 99 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06309225. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly | Trialion