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

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ClinicalTrials.gov Identifier: NCT01419002
Recruitment Status : Terminated (lack of recruitment)
First Posted : August 17, 2011
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Radiation: neoadjuvant RTx Procedure: Surgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Local recurrence free survival [ Time Frame: At 12 months postoperative ]

Secondary Outcome Measures :
  1. Percentage of surgical R0-resections in both groups [ Time Frame: Until 10 days postoperative ]
    Determined by histopathological analysis of the surgical specimen.

  2. 30-day morbidity and mortality [ Time Frame: 30 day period after the operation ]
  3. 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

  4. Clinical response rate (RECIST-criteria) and histological response rate [ Time Frame: Until 1 year postOP ]
  5. Time to tumor progression (local and systemic) [ Time Frame: Until 1 year postoperative ]
  6. Quality of life [ Time Frame: Until 12 months postoperative ]
  7. Overall survival after 1 year [ Time Frame: Until 1 year postoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: CHIR-Net
ClinicalTrials.gov Identifier: NCT01419002     History of Changes
Other Study ID Numbers: NetPac
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

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

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