Pancreatic Cancer Research

Clinical trialNo phase (not a drug trial)Completed

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

Outcome
Finished, no results posted
Phase
No phase (not a drug trial)
Status
Completed
Study type
Interventional
Start
1 May 2015
Ended
31 October 2016
Enrollment
10 participants
Sites
1
Primary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Sponsor type
Academic / other
Results posted
No
Last update
5 March 2020

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.