Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

Pancreatic Neoplasms Clinical Trial

— LAPC-1  

Official title:

Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292745
• Other study ID #: 2014- 00235039
• Secondary ID: 2014-002350-39
• Status: Completed
• Phase: N/A
• Start date: December 2, 2014
• Est. completion date: May 24, 2018

Study information

• Verified date: July 2020
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Cytological or histologically confirmation of pancreatic cancer.

• WHO performance status of 0 or 1

• ASA classification I or II

• Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy.

• No evidence of metastatic disease

• Largest tumor diameter < 7 cm x 7 cm x 7 cm

• Normal renal function (Creatinine = 30 ml/min).

• Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)

• Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l)

• Age > 18 years and < 75 years

• Written informed consent

Exclusion Criteria:

• Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).

• Lymph node metastases from primary tumor outside the field of radiation.

• Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence.

• Pregnancy, breast feeding.

• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Radiation:
• stereotactic radiotherapy

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Liver Research	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 3.5 years after start of therapy
Secondary	number of toxicity events related to chemotherapy		up to 3.5 years after start of therapy
Secondary	radiological response rates after chemotherapy and radiotherapy		up to 3.5 years after start of therapy
Secondary	number of resections at end of stereotactic radiotherapy		up to 3.5 years after start of therapy
Secondary	time to locoregional disease progression		up to 3.5 years after start of therapy
Secondary	time to development of distant metastases		up to 3.5 years after start of therapy
Secondary	predictive value of a set of biological markers for treatment response		up to 3.5 years after start of therapy