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

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.

Conditions

Oropharynx Cancer, Frailty

Study Overview

Study Details

Study overview

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.

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

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

Condition
Oropharynx Cancer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

65 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Omar Mahmoud,

Study Record Dates

2026-09-30