NCT01683422

Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

Terminated NA Results posted Last updated 10 August 2021

What this trial tests

NA trial testing Proton, Gemcitabine, Erlotinib, Capecitabine in Pancreatic Cancer in 9 participants. Terminated before completion.

Timeline

2 January 2013

Primary endpoint
19 February 2019

19 February 2019

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	2 January 2013
Primary completion	19 February 2019
Estimated completion	19 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Proton, Gemcitabine, Erlotinib, Capecitabine
• Proton Radiation

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Loma Linda University

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

One-year Survival Rate Primary · One year after treatment completed.

Subjects will be followed after treatment completed to determine length of survival rate. The primary study objective was 1-year overall survival (OS, failure: death due to any cause). The Kaplan-Meier method was used to estimate the one-year OS. Secondary Objectives were the frequency of serious adverse events, disease control rate and progression-free survival.

Group	Value	95% CI
Proton Radiation	55.6	31 – 99

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Proton Radiation

Serious: 9/9 (100%)

Deaths: 9/9

Serious adverse events (1 terms)

Reaction	System	Proton Radiation
serious	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Most-reported serious reactions: serious.

Data from ClinicalTrials.gov NCT01683422 adverse events section.

Sponsor's own description

The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.