Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01397019
First received: July 18, 2011
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.


Condition Intervention Phase
Pancreatic Cancer
Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 2 year survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRINOX Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin
FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors

Detailed Description:

Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (major)

  • non-metastatic pancreatic cancer
  • Performance status 0-1
  • Bilirubin < 1.5 UNL
  • Written informed consent

Exclusion Criteria: (major)

  • no prior abdominal radiotherapy
  • no prior chemotherapy for pancratic cancer
  • no severe comorbidity
  • patients must be able to undergo potential abdominal surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397019

Contacts
Contact: Jon K Bjerregaard, MD +45 65413834 jon.bjerregaard@ouh.regionsyddanmark.dk
Contact: Per Pfeiffer, Professor +45 6541 2921 per.pfeiffer@ouh.regionsyddanmark.dk

Locations
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9100
Contact: Mette Yilmaz, MD    +45 9932 1111    my@dadlnet.dk   
Principal Investigator: Mette Yilmaz, MD         
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Morten Ladekarl, MD    +45 8949 2565      
Principal Investigator: Morten Ladekarl, MD         
Herlev University Hospital Not yet recruiting
Herlev, Denmark, 2730
Contact: Benny V Jensen, MD    +45 3868 3868    bevi@heh.regionh.dk   
Principal Investigator: Benny V Jensen, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jon K Bjerregaard, MD    +45 6541 3834    jon.bjerregaard@ouh.regionsyddanmark.dk   
Contact: Per Pfeiffer, Professor    +45 6541 2921    per.pfeiffer@ouh.regionsyddanmark.dk   
Principal Investigator: Per Pfeiffer, Professor         
Sub-Investigator: Jon K Bjerregaard, MD         
Sub-Investigator: Michael B Mortensen, MD         
Sponsors and Collaborators
Per Pfeiffer
Investigators
Principal Investigator: Per Pfeiffer, Professor Odense University Hospital
  More Information

No publications provided

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01397019     History of Changes
Other Study ID Numbers: DPSG 2010-01
Study First Received: July 18, 2011
Last Updated: October 23, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Pancreatic cancer
Chemotherapy
Chemoradiotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Oxaliplatin
Irinotecan
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014