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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01419002 |
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Date of registration:
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13/08/2011 |
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Primary sponsor: |
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Public title:
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Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer
Net-Pac |
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Scientific title:
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Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01419002 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Andre L Mihaljevic, MD M.Sc. |
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Address:
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Telephone:
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+49 (0)89 4140 5145 |
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Email:
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mihaljevic@chir.med.tu-muenchen.de |
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Affiliation:
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Name:
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Andre L Mihaljevic, MD M.Sc. |
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Address:
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Telephone:
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+49 (0)89 4140 5145 |
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Email:
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mihaljevic@chir.med.tu-muenchen.de |
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Affiliation:
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Name:
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Helmut M Friess, Prof. MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technische Universität München |
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Name:
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Michael Molls, Prof. MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technische Universität München |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Adenocarcinoma
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Intervention(s)
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Procedure: Surgery
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Radiation: neoadjuvant RTx
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Primary Outcome(s)
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Local recurrence free survival
[Time Frame: At 12 months postoperative]
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Secondary Outcome(s)
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30-day morbidity and mortality
[Time Frame: 30 day period after the operation]
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Clinical response rate (RECIST-criteria) and histological response rate
[Time Frame: Until 1 year postOP]
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Overall survival after 1 year
[Time Frame: Until 1 year postoperative]
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Percentage of surgical R0-resections in both groups
[Time Frame: Until 10 days postoperative]
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Quality of life
[Time Frame: Until 12 months postoperative]
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Time to tumor progression (local and systemic)
[Time Frame: Until 1 year postoperative]
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Toxicity of preoperative Radiotherapy
[Time Frame: Start of the radiotherapy until 12 months postoperative.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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