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

This study has been terminated.
(lack of recruitment)
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
CHIR-Net
ClinicalTrials.gov Identifier:
NCT01419002
First received: August 13, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Pancreatic Adenocarcinoma
Radiation: neoadjuvant RTx
Procedure: Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial

Resource links provided by NLM:


Further study details as provided by CHIR-Net:

Primary Outcome Measures:
  • Local recurrence free survival [ Time Frame: At 12 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of surgical R0-resections in both groups [ Time Frame: Until 10 days postoperative ] [ Designated as safety issue: No ]
    Determined by histopathological analysis of the surgical specimen.

  • 30-day morbidity and mortality [ Time Frame: 30 day period after the operation ] [ Designated as safety issue: Yes ]
  • Toxicity of preoperative Radiotherapy [ Time Frame: Start of the radiotherapy until 12 months postoperative. ] [ Designated as safety issue: Yes ]
    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 Frame: Until 1 year postOP ] [ Designated as safety issue: Yes ]
  • Time to tumor progression (local and systemic) [ Time Frame: Until 1 year postoperative ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Until 12 months postoperative ] [ Designated as safety issue: Yes ]
  • Overall survival after 1 year [ Time Frame: Until 1 year postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Intensity modulated beam radiation (IMBR).
Active Comparator: Surgery Procedure: Surgery
Surgery and adjuvant chemotherapy according to German S3-guidelines
Other Name: Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419002

Locations
Germany
Klinikum rechts der Isar, Technische Universität München
Munich, Germany, 81675
Sponsors and Collaborators
CHIR-Net
Technische Universität München
Investigators
Principal Investigator: Helmut M Friess, Prof. MD Technische Universität München
Study Director: Michael Molls, Prof. MD Technische Universität München
  More Information

Additional Information:
No publications provided

Responsible Party: CHIR-Net
ClinicalTrials.gov Identifier: NCT01419002     History of Changes
Other Study ID Numbers: NetPac
Study First Received: August 13, 2011
Last Updated: May 24, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by CHIR-Net:
Pancreatic Cancer
Adenocarcinoma
Neoadjuvant Radiotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014