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

NCT ID: NCT02292745

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-02
• Study Completion Date: 2018-05-24

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.

Conditions

Pancreatic Neoplasms

Study Design

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

Study Groups

Stereotactic radiotherapy

Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy

Group Type: EXPERIMENTAL

stereotactic radiotherapy

Intervention Type: RADIATION

Interventions

stereotactic radiotherapy

Intervention Type: RADIATION

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.

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

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Foundation for Liver Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. C.H.J. van Eijck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 31891135 (View on PubMed)

Other Identifiers

2014-002350-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014- 00235039

Identifier Type: -

Identifier Source: org_study_id