NCT03401827

Brief Summary

Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 12, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

December 30, 2017

Last Update Submit

February 8, 2018

Conditions

Pancreatic AdenocarcinomaChemotherapy Effect

Keywords

pancreatic cancersecond line chemotherapynab-paclitaxel

Outcome Measures

Primary Outcomes (1)

  • survival rate

    survival rate at 6 months after 2nd line chemotherapy

    6 months

Secondary Outcomes (4)

  • overall survival

    till death or follow-up loss or end of study up to 2 years

  • Progression free survival

    till death or follow-up loss or end of study up to 2 years

  • Disease control rate

    6 months

  • adverse event

    till death or follow-up loss or end of study up to 2 years

Study Arms (1)

Gemcitabine + nab-paclitaxel

EXPERIMENTAL

Case with chemotherapy (Gemcitabine + nab-paclitaxel)

Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)

Interventions

Chemotherapy (Gemcitabine + nab-paclitaxel)DRUG

Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15 Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15

Also known as: GnP
Gemcitabine + nab-paclitaxel

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient whose age is 20 years or older
  • ECOG Performance Status 0-2
  • Pathologically confirmed pancreatic adenocarcinoma
  • Patients with locally advanced or distant metastasis status
  • Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed
  • Patients whose consent was obtained (non-insurance agreement)

You may not qualify if:

  • Those who can not obtain consent
  • Those who refuse chemotherapy
  • ECOG Performance Status 3 or higher
  • Multiple organ failure is accompanied
  • Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month
  • Allergy to the test drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

  • Huh G, Lee HS, Choi JH, Lee SH, Paik WH, Ryu JK, Kim YT, Bang S, Lee ES. Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial. Ther Adv Med Oncol. 2021 Nov 10;13:17588359211056179. doi: 10.1177/17588359211056179. eCollection 2021.

    PMID: 34790261DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug TherapyGemcitabine130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Sang Hyub Lee, MD, Ph.D

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jin Ho Choi, MD

CONTACT

82-2-2072-2228pseudo.jh@gmail.com

Sang Hyub Lee, MD, Ph.D

CONTACT

82-2-2072-2228gidoctor@korea.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 17, 2018

Study Start

March 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 12, 2018

Record last verified: 2018-01

Locations

KR(1)