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Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer. (LAPC-1)

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
stereotactic radiotherapy
Sponsored by
Foundation for Liver Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring locally advanced pancreatic cancer, chemotherapy, stereotactic radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic radiotherapy

Arm Description

Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

number of toxicity events related to chemotherapy
radiological response rates after chemotherapy and radiotherapy
number of resections at end of stereotactic radiotherapy
time to locoregional disease progression
time to development of distant metastases
predictive value of a set of biological markers for treatment response

Full Information

First Posted
July 28, 2014
Last Updated
July 28, 2020
Sponsor
Foundation for Liver Research
Collaborators
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02292745
Brief Title
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Acronym
LAPC-1
Official Title
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2, 2014 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Liver Research
Collaborators
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
locally advanced pancreatic cancer, chemotherapy, stereotactic radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic radiotherapy
Arm Type
Experimental
Arm Description
Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
up to 3.5 years after start of therapy
Secondary Outcome Measure Information:
Title
number of toxicity events related to chemotherapy
Time Frame
up to 3.5 years after start of therapy
Title
radiological response rates after chemotherapy and radiotherapy
Time Frame
up to 3.5 years after start of therapy
Title
number of resections at end of stereotactic radiotherapy
Time Frame
up to 3.5 years after start of therapy
Title
time to locoregional disease progression
Time Frame
up to 3.5 years after start of therapy
Title
time to development of distant metastases
Time Frame
up to 3.5 years after start of therapy
Title
predictive value of a set of biological markers for treatment response
Time Frame
up to 3.5 years after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. C.H.J. van Eijck, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31891135
Citation
Suker M, Nuyttens JJ, Eskens FALM, Haberkorn BCM, Coene PLO, van der Harst E, Bonsing BA, Vahrmeijer AL, Mieog JSD, Jan Swijnenburg R, Roos D, Koerkamp BG, van Eijck CHJ. Efficacy and feasibility of stereotactic radiotherapy after folfirinox in patients with locally advanced pancreatic cancer (LAPC-1 trial). EClinicalMedicine. 2019 Nov 19;17:100200. doi: 10.1016/j.eclinm.2019.10.013. eCollection 2019 Dec.
Results Reference
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Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

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