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

Primary Purpose

Pancreatic Adenocarcinoma

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
neoadjuvant RTx
Surgery
Sponsored by
CHIR-Net
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum rechts der Isar, Technische Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant RTx

Surgery

Arm Description

Outcomes

Primary Outcome Measures

Local recurrence free survival

Secondary Outcome Measures

Percentage of surgical R0-resections in both groups
Determined by histopathological analysis of the surgical specimen.
30-day morbidity and mortality
Toxicity of preoperative Radiotherapy
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
Clinical response rate (RECIST-criteria) and histological response rate
Time to tumor progression (local and systemic)
Quality of life
Overall survival after 1 year

Full Information

First Posted
August 13, 2011
Last Updated
July 27, 2015
Sponsor
CHIR-Net
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01419002
Brief Title
Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer
Acronym
Net-Pac
Official Title
Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHIR-Net
Collaborators
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
Pancreatic Cancer, Adenocarcinoma, Neoadjuvant Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant RTx
Arm Type
Experimental
Arm Title
Surgery
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant RTx
Other Intervention Name(s)
Intensity modulated beam radiation (IMBR).
Intervention Description
Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple
Intervention Description
Surgery and adjuvant chemotherapy according to German S3-guidelines
Primary Outcome Measure Information:
Title
Local recurrence free survival
Time Frame
At 12 months postoperative
Secondary Outcome Measure Information:
Title
Percentage of surgical R0-resections in both groups
Description
Determined by histopathological analysis of the surgical specimen.
Time Frame
Until 10 days postoperative
Title
30-day morbidity and mortality
Time Frame
30 day period after the operation
Title
Toxicity of preoperative Radiotherapy
Description
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
Time Frame
Start of the radiotherapy until 12 months postoperative.
Title
Clinical response rate (RECIST-criteria) and histological response rate
Time Frame
Until 1 year postOP
Title
Time to tumor progression (local and systemic)
Time Frame
Until 1 year postoperative
Title
Quality of life
Time Frame
Until 12 months postoperative
Title
Overall survival after 1 year
Time Frame
Until 1 year postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut M Friess, Prof. MD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Molls, Prof. MD
Organizational Affiliation
Technical University of Munich
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum rechts der Isar, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://tumstrahlen.einzelportal.de/
Description
Department of Radiation Oncology, Technische Universität München

Learn more about this trial

Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

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