Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Oxaliplatin, irinotecan, 5-FU & leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Chemotherapy, Chemoradiotherapy
Eligibility 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
Sites / Locations
- Aarhus University Hospital
- Herlev University Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFIRINOX
Arm Description
Outcomes
Primary Outcome Measures
2 year survival rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01397019
Brief Title
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
Official Title
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Pfeiffer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Chemotherapy, Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRINOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, irinotecan, 5-FU & leucovorin
Intervention Description
FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors
Primary Outcome Measure Information:
Title
2 year survival rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Pfeiffer, Professor
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
We'll reach out to this number within 24 hrs