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

NCT ID: NCT01397019

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-02-28

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRINOX

Group Type: EXPERIMENTAL

Oxaliplatin, irinotecan, 5-FU & leucovorin

Intervention Type: DRUG

FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors

Interventions

Oxaliplatin, irinotecan, 5-FU & leucovorin

FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• no prior abdominal radiotherapy
• no prior chemotherapy for pancratic cancer
• no severe comorbidity
• patients must be able to undergo potential abdominal surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Per Pfeiffer

OTHER

Sponsor Role: lead

Responsible Party

Per Pfeiffer

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Per Pfeiffer, Professor

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Herlev University Hospital

Herlev, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

DPSG 2010-01

Identifier Type: -

Identifier Source: org_study_id