Clinical trial NCT02292745: Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Official title: Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: locally advanced pancreatic cancer
chemotherapy
stereotactic radiotherapy
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2014-11-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: overall survival
timeFrame: up to 3.5 years after start of therapy
Secondary outcomes:
measure: number of toxicity events related to chemotherapy
timeFrame: up to 3.5 years after start of therapy
measure: radiological response rates after chemotherapy and radiotherapy
timeFrame: up to 3.5 years after start of therapy
measure: number of resections at end of stereotactic radiotherapy
timeFrame: up to 3.5 years after start of therapy
measure: time to locoregional disease progression
timeFrame: up to 3.5 years after start of therapy
measure: time to development of distant metastases
timeFrame: up to 3.5 years after start of therapy
measure: predictive value of a set of biological markers for treatment response
timeFrame: up to 3.5 years after start of therapy
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Prof. C.H.J. van Eijck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.