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

NCT ID: NCT01419002

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant RTx

Group Type EXPERIMENTAL

neoadjuvant RTx

Intervention Type RADIATION

Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.

Surgery

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Surgery and adjuvant chemotherapy according to German S3-guidelines

Interventions

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neoadjuvant RTx

Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.

Intervention Type RADIATION

Surgery

Surgery and adjuvant chemotherapy according to German S3-guidelines

Intervention Type PROCEDURE

Other Intervention Names

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Intensity modulated beam radiation (IMBR). Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role collaborator

CHIR-Net

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helmut M Friess, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Michael Molls, Prof. MD

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

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Klinikum rechts der Isar, Technische Universität München

Munich, , Germany

Site Status

Countries

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Germany

Related Links

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http://tumstrahlen.einzelportal.de/

Department of Radiation Oncology, Technische Universität München

Other Identifiers

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NetPac

Identifier Type: -

Identifier Source: org_study_id

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