Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer (Net-Pac)
This study is not yet open for participant recruitment.
Verified August 2011 by CHIR-Net
Sponsor:
CHIR-Net
Collaborator:
Technische Universität München
Information provided by:
CHIR-Net
ClinicalTrials.gov Identifier:
NCT01419002
First received: August 13, 2011
Last updated: August 16, 2011
Last verified: August 2011
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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 ]
| Estimated Enrollment: | 120 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419002
Contacts
| Contact: Andre L Mihaljevic, MD M.Sc. | +49 (0)89 4140 5145 | mihaljevic@chir.med.tu-muenchen.de |
| Contact: Michael Kranzfelder, MD | +49 (0)89 4140 2121 | kranzfelder@chir.med.tu-muenchen.de |
Locations
| Germany | |
| Klinikum rechts der Isar, Technische Universität München | Not yet recruiting |
| Munich, Germany, 81675 | |
| Contact: Andre L Mihaljevic, MD M.Sc. +49 (0)89 4140 5145 mihaljevic@chir.med.tu-muenchen.de | |
| Principal Investigator: Helmut M Friess, Prof. MD | |
| Principal Investigator: Michael Molls, Prof. MD | |
| Sub-Investigator: Hans Geinitz, PD MD | |
| Sub-Investigator: Michael Kranzfelder, MD | |
| Sub-Investigator: Andre Mihaljevic, MD | |
| Sub-Investigator: Peter Buechler, MD | |
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: | Helmut Friess, Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany |
| ClinicalTrials.gov Identifier: | NCT01419002 History of Changes |
| Other Study ID Numbers: | NetPac |
| Study First Received: | August 13, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Germany: Federal Office for Radiation Protection |
Keywords provided by CHIR-Net:
|
Pancreatic Cancer Adenocarcinoma Neoadjuvant Radiotherapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 22, 2013