Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer (Net-Pac)

July 27, 2015 updated by: CHIR-Net

Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial

Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Klinikum rechts der Isar, Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the pancreatic head
  • Age ≥ 18 years
  • Signed informed consent
  • ECOG performance status of 0-2

Exclusion Criteria:

  • Curative resection is not feasible or presence of metastatic disease
  • Patients not eligible for surgery (ASA ≥ 4)
  • Participation in an other clinical trial
  • Unable or unwilling to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery
Procedure: Surgery
Surgery and adjuvant chemotherapy according to German S3-guidelines
Other Names:
  • Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple
Experimental: Neoadjuvant RTx
Radiation: neoadjuvant RTx
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
Other Names:
  • Intensity modulated beam radiation (IMBR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local recurrence free survival
Time Frame: At 12 months postoperative
At 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of surgical R0-resections in both groups
Time Frame: Until 10 days postoperative
Determined by histopathological analysis of the surgical specimen.
Until 10 days postoperative
30-day morbidity and mortality
Time Frame: 30 day period after the operation
30 day period after the operation
Toxicity of preoperative Radiotherapy
Time Frame: Start of the radiotherapy until 12 months postoperative.
Number of patients with adverse events in both groups, number of adverse events in both groups and number of grade 3 and 4 adverse events according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) in both groups
Start of the radiotherapy until 12 months postoperative.
Clinical response rate (RECIST-criteria) and histological response rate
Time Frame: Until 1 year postOP
Until 1 year postOP
Time to tumor progression (local and systemic)
Time Frame: Until 1 year postoperative
Until 1 year postoperative
Quality of life
Time Frame: Until 12 months postoperative
Until 12 months postoperative
Overall survival after 1 year
Time Frame: Until 1 year postoperative
Until 1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHIR-Net

Collaborators

Technical University of Munich

Investigators

  • Principal Investigator: Helmut M Friess, Prof. MD, Technical University of Munich
  • Study Director: Michael Molls, Prof. MD, Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 13, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NetPac

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Clinical Trials on neoadjuvant RTx

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe