Phase I-II Study of Chemoradiotherapy Using Carboplatin and Paclitaxel for Elderly Patients With Esophagus Cancer

What this Trial Is About

Managing cancer in elderly patients is a complex challenge, especially since many with esophageal cancer are older and often unfit for surgery. Standard chemoradiotherapy CRT using cisplatin and 5FU infusion combined with external beam radiotherapy EBRT can cause severe toxicities, and its effectiveness in patients over 75 years has not been well studied. This research aims to assess a different chemotherapy combination with radiotherapy in elderly patients to find safer and effective treatment options. This phase III study evaluates chemoradiation therapy using carboplatin and paclitaxel alongside radiotherapy in elderly patients with esophageal cancer. The study tests different dose levels of chemotherapy 50%, 75%, and 100% of a standard Dutch regimen and radiotherapy doses 41.4 Gy, 45 Gy, and 50.4 Gy to find the maximum tolerated dose and recommended doses for phase II. The treatment is delivered concurrently over about five weeks, with the phase I focusing on dose escalation and phase II assessing tumor response. Participants aged 75 to 100 years with specific stages of esophageal cancer will be closely monitored during and after treatment. Researchers will measure the maximum tolerated dose one month after treatment ends and track quality of life, progression-free survival, and overall survival over three years. The study includes careful assessments of physical health, bone marrow, kidney, and liver function to ensure safety and effectiveness throughout the treatment and follow-up periods.

Chemoradiotherapy in Elderly Patients With Oesophagus Cancer