Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2 year survival rate
2 years
No
Per Pfeiffer, Professor
Principal Investigator
Odense University Hospital
Denmark: Ethics Committee
DPSG 2010-01
NCT01397019
October 2011
October 2015
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