NCT02626520

Brief Summary

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

December 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

November 13, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

December 3, 2015

Results QC Date

July 13, 2018

Last Update Submit

October 12, 2018

Conditions

Ductal Adenocarcinoma of PancreasAdenocarcinoma of Ampulla

Outcome Measures

Primary Outcomes (1)

  • Relapse Free Survival

    Percentage of patients alive and free of detectable disease 1 yr from start of treatment

    1 yr form onset of treatment

Secondary Outcomes (2)

  • R-0 Rate

    Time of surgery

  • Overall Survival

    Up to 3 years from registration

Study Arms (2)

Resectable, Low Risk

EXPERIMENTAL

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Drug: Gemcitabine and nanoparticle albumin bound paclitaxelProcedure: Definitive resection

Locally Advanced

EXPERIMENTAL

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Drug: Gemcitabine and nanoparticle albumin bound paclitaxelDrug: 5-fluorouracil and irinotecanRadiation: Preoperative chemoradiationProcedure: Definitive resection

Interventions

Gemcitabine and nanoparticle albumin bound paclitaxelDRUG

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Also known as: Gem/Abraxane, Gemcitabine/nab-paclitaxel
Locally AdvancedResectable, Low Risk
5-fluorouracil and irinotecanDRUG

FOLFIRI.3 given every 14 days x 4 cycles

Also known as: FOLFIRI.3, FOLFIRI-3
Locally Advanced
Preoperative chemoradiationRADIATION

Pre-operative chemoradiation to 40 Gy in 20 fractions

Locally Advanced
Definitive resectionPROCEDURE

Definitive surgical resection of primary tumor

Also known as: pancreaticoduodenectomy, Whipple procedure
Locally AdvancedResectable, Low Risk

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
  • Fitness for chemotherapy in judgement of treating physician
  • Bilirubin \< 4 (any means of biliary drainage acceptable)

You may not qualify if:

  • Medical or mental illness precluding provision of informed consent
  • Pregnancy
  • Active infection for which neutropenia would pose high risk of mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Interventions

GemcitabineTaxesFluorouracilIrinotecanPancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingEconomicsHealth Care Economics and OrganizationsUracilPyrimidinonesCamptothecinAlkaloidsDigestive System Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Bret Friday
Organization
Essentia Health
bret.friday@essentiahealth.org
218-786-3625

Study Officials

  • Peter Kebbekus, MD, PhD

    Essentia Health Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 10, 2015

Study Start

May 11, 2016

Primary Completion

September 20, 2016

Study Completion

September 14, 2017

Last Updated

November 13, 2018

Results First Posted

November 13, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

We will make unidentified dataset available for electronic download.

Available IPD Datasets

Study Protocol Access

Locations

US(1)