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

Pancreatic Cancer Clinical Trial

Official title:

Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397019
• Other study ID #: DPSG 2010-01
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: February 2018

Study information

• Verified date: October 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Oxaliplatin, irinotecan, 5-FU & leucovorin
FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Herlev University Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Per Pfeiffer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year survival rate		2 years