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

NCT01419002 | Terminated Phase 3

• 1 other identifier: NetPac
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic Cancer; Adenocarcinoma; Neoadjuvant Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Local recurrence free survival

  At 12 months postoperative

Secondary Outcomes (7)

• Percentage of surgical R0-resections in both groups

  Until 10 days postoperative

• 30-day morbidity and mortality

  30 day period after the operation

• Toxicity of preoperative Radiotherapy

  Start of the radiotherapy until 12 months postoperative.

• Clinical response rate (RECIST-criteria) and histological response rate

  Until 1 year postOP

• Time to tumor progression (local and systemic)

  Until 1 year postoperative

Study Arms (2)

Neoadjuvant RTx

EXPERIMENTAL

Radiation: neoadjuvant RTx

Surgery

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

neoadjuvant RTx RADIATION

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

Also known as: Intensity modulated beam radiation (IMBR).

Neoadjuvant RTx

Surgery PROCEDURE

Surgery and adjuvant chemotherapy according to German S3-guidelines

Also known as: Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the pancreatic head
• Age ≥ 18 years
• Signed informed consent
• ECOG performance status of 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• CHIR-Net: lead
• Technical University of Munich: collaborator

Study Sites (1)

Klinikum rechts der Isar, Technische Universität München

Munich, 81675, Germany

Location

Related Links

• Department of Radiation Oncology, Technische Universität München

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

Surgical Procedures, Operative; Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Study Officials

• Helmut M Friess, Prof. MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Michael Molls, Prof. MD

  Technical University of Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2011
• First Posted: August 17, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

DE (1)