Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic cancer, Chemotherapy, Chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin, irinotecan, 5-FU & leucovorin
Type: Drug
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Aalborg University Hospital
Aalborg, Denmark
Status: Not yet recruiting
Contact: Mette Yilmaz, MD - +45 9932 1111 - my@dadlnet.dk
Aarhus University Hospital
Aarhus, Denmark
Status: Not yet recruiting
Contact: Morten Ladekarl, MD - +45 8949 2565
Herlev University Hospital
Herlev, Denmark
Status: Not yet recruiting
Contact: Benny V Jensen, MD - +45 3868 3868 - bevi@heh.regionh.dk
Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Jon K Bjerregaard, MD - +45 6541 3834 - jon.bjerregaard@ouh.regionsyddanmark.dk
Start Date
October 2011
Completion Date
October 2015
Sponsors
Per Pfeiffer
Source
Odense University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page