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

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

Official title: CIPHER: A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion Versus Conventional Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial Description

To compare the efficacy of carbon ion-based chemo radiotherapy with x-ray-based chemo radiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment.

Patient has 2 in 3 chance of receiving Arm A and 1 in 3 chance of receiving Arm B.

Arm A (chemoradiation takes place in Japan):

CIRT in 12 fractions/treatments plus concurrent gemcitabine, followed by 4 cycles of gemcitabine + nab-Paclitaxel, or until progression or intolerance of therapy

Arm B:

IMRT in 28 fractions plus concurrent gemcitabine or capecitabine, followed by 4 cycles of gemcitabine + nab-Paclitaxel, or until progression or intolerance of therapy

Per investigator discretion, patients may receive either:

1. Definitive treatment :

2. Neoadjuvant treatment:

Adjuvant chemotherapy 4 cycles of gemcitabine/nab-paclitaxel or FOLFIRNOX, Gemcitabine alone if these regimens are unavailable ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Locally Advanced Pancreatic Adenocarcinoma

• NCT number: NCT03536182
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 29, 2019
• Completion date: July 1, 2023