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

Launched by OMAR MAHMOUD · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat oropharynx cancer, which is a type of cancer found in the throat area, particularly in older adults. The goal is to see if using lower doses of radiation and smaller treatment areas can still effectively control the cancer while causing fewer side effects compared to the usual high-dose treatments. Previous research has shown that high-dose treatments can be effective but often lead to significant side effects, so this study is exploring whether a gentler approach can provide similar success without as many long-term problems.

To participate in this trial, a patient must be at least 65 years old and have a confirmed diagnosis of oropharynx cancer that meets specific criteria. This includes having measurable disease and being positive for a certain marker (P16) that is associated with this type of cancer. During the study, participants will receive the new treatment regimen and will be monitored to compare their results with what is known from traditional treatments. This research aims to find out if a less intense treatment can keep patients healthy and free from cancer while minimizing the side effects that can affect their quality of life.

Gender

ALL

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