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

Per Pfeiffer

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT01397019

DPSG 2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

FOLFIRINOX

Experimental group

Treatment:

Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin