NCT02292745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

December 2, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

July 28, 2014

Last Update Submit

July 28, 2020

Conditions

Pancreatic Neoplasms

Keywords

locally advanced pancreatic cancerchemotherapystereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    up to 3.5 years after start of therapy

Secondary Outcomes (6)

  • number of toxicity events related to chemotherapy

    up to 3.5 years after start of therapy

  • radiological response rates after chemotherapy and radiotherapy

    up to 3.5 years after start of therapy

  • number of resections at end of stereotactic radiotherapy

    up to 3.5 years after start of therapy

  • time to locoregional disease progression

    up to 3.5 years after start of therapy

  • time to development of distant metastases

    up to 3.5 years after start of therapy

  • +1 more secondary outcomes

Study Arms (1)

Stereotactic radiotherapy

EXPERIMENTAL

Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy

Radiation: stereotactic radiotherapy

Interventions

stereotactic radiotherapyRADIATION
Stereotactic radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 31891135DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Prof. C.H.J. van Eijck, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

November 17, 2014

Study Start

December 2, 2014

Primary Completion

May 24, 2018

Study Completion

May 24, 2018

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

NL(1)