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

Pancreatic Adenocarcinoma Clinical Trial

— Net-Pac  

Official title:

Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01419002
• Other study ID #: NetPac
• Status: Terminated
• Phase: Phase 3
• First received: August 13, 2011
• Last updated: July 27, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: CHIR-Net
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

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

Procedure:
• Surgery
Surgery and adjuvant chemotherapy according to German S3-guidelines

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Technische Universität München	Munich

Sponsors (2)

Lead Sponsor	Collaborator
CHIR-Net	Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence free survival		At 12 months postoperative	No
Secondary	Percentage of surgical R0-resections in both groups	Determined by histopathological analysis of the surgical specimen.	Until 10 days postoperative	No
Secondary	30-day morbidity and mortality		30 day period after the operation	Yes
Secondary	Toxicity of preoperative Radiotherapy	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	Start of the radiotherapy until 12 months postoperative.	Yes
Secondary	Clinical response rate (RECIST-criteria) and histological response rate		Until 1 year postOP	Yes
Secondary	Time to tumor progression (local and systemic)		Until 1 year postoperative	No
Secondary	Quality of life		Until 12 months postoperative	Yes
Secondary	Overall survival after 1 year		Until 1 year postoperative	Yes

External Links

•   CHIR-Net homepage
•   Department of Radiation Oncology, Technische Universität München
•   Department of Surgery, Technische Universität München