RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)

Quick Facts

Study Start:2025-05-15
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06309225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
  2. * Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
  3. * P16-positive based on local site immunohistochemical tissue staining
  4. * Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
  5. * Age ≥ 65.
  6. * Normal organ and marrow function within 14 days prior to registration defined as follows:
  7. * Absolute neutrophil count ≥ 1,500/mcL
  8. * Platelets ≥ 100,000/mcL
  9. * Hemoglobin ≥ 8.0 g/dL
  10. * Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
  11. * AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
  12. * Serum creatinine ≤ 1.5× ULN
  1. * Metastatic disease
  2. * Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
  3. * Synchronous double primaries
  4. * Prior radiotherapy for lymphoma or other malignancy
  5. * Prior systemic therapy including immunotherapy
  6. * Severe active comorbidity where life expectancy is \<1 year.
  7. * Autoimmune disease
  8. * Uncontrolled HIV

Contacts and Locations

Study Contact

Regulatory Office
CONTACT
904-202-7300
RegBMDA@bmcjax.com
Clinical Trials Office
CONTACT
clinicaltrialsdivision@bmcjax.com

Study Locations (Sites)

Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States

Collaborators and Investigators

Sponsor: Omar Mahmoud

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Oropharynx Cancer
  • Frailty