NCT03949933

Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shanghai Proton and Heavy Ion Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for locally advanced pancreatic carcinoma (LAPC)

Detailed description

The proton dose of 50.4GyE in 28 fractions was delivered to clinical target volume (CTV), and carbon ion as a boost dose to gross tumor volume (GTV) escalated from 12GyE to 18GyE with 3GyE per fraction in 3 dose levels. The dose limiting toxicity (DLT) was defined as CTCAE grade 3 or higher of non-hematological toxicity (G3). The acute and late toxicities, overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS) and distant metastasis-free survival (DMFS) were the endpoints.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
RADIATION	proton and carbon ion radiotherapy	proton and carbon ion radiotherapy

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-31
• Completion: 2016-10-31
• First posted: 2019-05-14
• Last updated: 2020-03-05

Locations

1 site across 1 country: China