Last updated on August 2019

Trial of Carbon Ion Versus Photon Radiotherapy for Locally Advanced Unresectable Pancreatic Cancer


Brief description of study

To determine if carbon ion radiotherapy improves overall survival versus photon therapy in patients with locally advanced, unresectable pancreatic cancer

Detailed Study Description

A significant percentage of patients with incurable pancreatic cancer die with predominantly local disease. Conventional chemoradiotherapy (i.e. using photon therapy) leads to inadequate locoregional control rates, despite concurrent chemotherapy and modern radiation techniques. Carbon ion radiation therapy holds the promise of a novel biological mechanism for eradicating local-only disease (heavy ion therapy), and preliminary data are extremely encouraging. Thus, evaluating the comparative effectiveness of a novel and more potent radiotherapy modality in this known radioresistant, lethal disease is a natural question.

This is a randomized phase III trial comparing photon-based (IMRT) and carbon-ion based (CIRT) chemoradiotherapy treatments. Patients will be randomized in a 2:1 ratio (CIRT:IMRT) to one of the following two treatment arms following non-progressive disease during induction

chemotherapy
  • Carbon ion-based irradiation (CIRT). Patients will be treated with carbon ion irradiation plus concurrent gemcitabine chemotherapy. This chemoradiation course is followed by treatment with gemcitabine and nab-paclitaxel chemotherapy.
  • Photon-based irradiation (IMRT). Patients will be treated with x-ray irradiation (IMRT) plus concurrent gemcitabine chemotherapy. This chemoradiation course is followed by treatment with gemcitabine and nab-paclitaxel chemotherapy.

Clinical Study Identifier: NCT03536182

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