Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01419002
Other study ID # NetPac
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Completed NCT01959672 - Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT03673423 - Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Not yet recruiting NCT06026943 - Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer N/A
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT02072616 - Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. Phase 3
Completed NCT02174887 - Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer Phase 1
Recruiting NCT03703063 - Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer Phase 1
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT03073785 - Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer Phase 2
Completed NCT03665441 - Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC Phase 3
Recruiting NCT04627246 - Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer Phase 1
Not yet recruiting NCT06217666 - Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC) Phase 1
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04119362 - PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Completed NCT03105921 - Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma N/A