NCT02125136

Brief Summary

The aim ot the study is to investigate the efficacy and safety of two new intensified chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and consecutive conversion of the tumor to resectability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_2

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

April 11, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

April 11, 2014

Last Update Submit

December 14, 2021

Conditions

Ductal Adenocarcinoma of the Pancreas

Keywords

unresectableborderline resectable

Outcome Measures

Primary Outcomes (1)

  • Conversion Rate

    To compare the effect of intensified neoadjuvant chemotherapy on conversion rate to resectability in LAPC.

    approx. 10 month

Secondary Outcomes (11)

  • Safety

    approx. 22 month

  • objective tumour response rate

    approx. 22 month

  • disease control rate (DCR)

    approx. 22 month

  • CA 19-9 change

    10 month

  • R0 and R1 resections

    10 month

  • +6 more secondary outcomes

Study Arms (2)

Gem/nab-Pac

EXPERIMENTAL

2 further cycles Gem/nab-Pac (duration of each cycle 28 days)

Drug: Gem/nab-Pac

FOLFIFINOX

EXPERIMENTAL

4 cycles combination therapy with 5-fluorouracil/folinic acid, irinotecan, oxaliplatin (FOLFIFINOX) - duration of each cycle 14 days

Drug: FOLFIFINOX

Interventions

Gem/nab-PacDRUG

All patient receive: 2 cycles gemcitabine/nab-paclitaxel (\[Gem/nab-Pac\]; duration of each cycle 28 days) Then: Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m2 as a 30-minute IV infusion on D1, D8, D15 of each 28-day cycle

Gem/nab-Pac
FOLFIFINOXDRUG

All patient receive: 2 cycles gemcitabine/nab-paclitaxel (\[Gem/nab-Pac\]; duration of each cycle 28 days) Then: Oxaliplatin 85 mg/m2, given as a 2-hour intravenous infusion D1 Folinic acid 400 mg/m2, given as a 2-hour intravenous infusion D1 Irinotecan 180 mg/m2, given as a 90-minutes intravenous infusion D1 (application through a Y-connector parallel to infusion of folinic acid or 30 minutes after start of folinic acid possible) Fluorouracil 400 mg/m2, administered by intravenous bolus, followed by a continuous intravenous infusion of fluorouracil 2400 mg/m2 over a 46-hour period D1. To be repeated on D1 of each cycle.

FOLFIFINOX

Eligibility Criteria

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

You may qualify if:

  • Adult patients ≥ 18 years and ≤ 75 years of age
  • Histologic or cytologic proven ductal adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
  • No distant metastases
  • De novo, treatment-naïve unresectable or borderline resectable LAPC; evaluation of unresectable and borderline resectable status according to NCCN- Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma" version 1.2013. Applicable criterion/criteria have to be indicated.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Total bilirubin ≤ 2 mg/dL. Patients with a biliary stent may be included provided that bilirubin level after stent insertion decreased to ≤ 2 mg/dL and there is no cholangitis.
  • Adequate renal, hepatic and bone marrow function, defined as
  • Serum creatinine ≤ 1.25 x Upper limit of normal (ULN)
  • Calculated creatinine clearance ≥ 60 mL/min according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  • Aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase)GOT and/or Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (GPT) ≤ 2.5 x ULN
  • Partial thromboplastin time (PTT) ≤ 1.5 x ULN and Quick value ≥ 70%
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Haemoglobin ≥ 8g/dL
  • Platelets ≥ 100 x 109/L
  • Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use effective contraceptive birth control measures (Pearl Index \< 1) during the course of the trial and for at least 1 month after last application of study treatment.
  • +4 more criteria

You may not qualify if:

  • Evidence of distant metastases. In case of radiological suspicion of peritoneal carcinomatosis or ascites histological or cytological verification is required e.g. by means of exploratory laparoscopy
  • Local relapse of the pancreatic adenocarcinoma prior treated with surgical resection
  • Any previous treatment of the pancreatic carcinoma (radiotherapy, chemoradiotherapy, chemotherapy, targeted tumor therapy, local ablative therapy)
  • Contraindication for pancreas resection (pancreatic head resection, distal pancreatectomy with splenectomy, or complete pancreatectomy)
  • Larger surgical interventions within 4 weeks before study enrolment and/or diagnostic laparotomy with or without gastroenterostomy and with or without biliodigestive anastomosis within 2 weeks before first application of study treatment. Wound healing must be also completed before first application of study treatment.
  • Known chronic diarrhoea
  • Peripheral polyneuropathy \> grade 1
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
  • Hypersensitivity against any of the study drugs (nab-paclitaxel, gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid), or the ingredients of these drugs
  • Active or uncontrolled bacterial, viral, or fungal infection that requires systemic treatment
  • Known HIV- infection or active Hepatitis B virus (HBV)- or Hepatitis C virus (HCV) infection
  • Convulsion disorder that requires anticonvulsive treatment
  • Clinically significant cardiovascular or vascular disease or disorder ≤ 6 months before study enrolment (e.g. myocardial infarction, unstable angina pectoris, chronic heart failure New York Heart Association (NYHA) ≥ grade 2, uncontrolled arrhythmia, cerebral infarction)
  • Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study or interfere with interpretation of study results e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Würzburg/Comprehensive Cancer Center Mainfranken

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (2)

  • Hartlapp I, Valta-Seufzer D, Siveke JT, Algul H, Goekkurt E, Siegler G, Martens UM, Waldschmidt D, Pelzer U, Fuchs M, Kullmann F, Boeck S, Ettrich TJ, Held S, Keller R, Anger F, Germer CT, Stang A, Kimmel B, Heinemann V, Kunzmann V; German Pancreatic Cancer Group (AIO-PAK) and NEOLAP investigators. Prognostic and predictive value of CA 19-9 in locally advanced pancreatic cancer treated with multiagent induction chemotherapy: results from a prospective, multicenter phase II trial (NEOLAP-AIO-PAK-0113). ESMO Open. 2022 Aug;7(4):100552. doi: 10.1016/j.esmoop.2022.100552. Epub 2022 Aug 12.

    PMID: 35970013DERIVED

  • Kunzmann V, Siveke JT, Algul H, Goekkurt E, Siegler G, Martens U, Waldschmidt D, Pelzer U, Fuchs M, Kullmann F, Boeck S, Ettrich TJ, Held S, Keller R, Klein I, Germer CT, Stein H, Friess H, Bahra M, Jakobs R, Hartlapp I, Heinemann V; German Pancreatic Cancer Working Group (AIO-PAK) and NEOLAP investigators. Nab-paclitaxel plus gemcitabine versus nab-paclitaxel plus gemcitabine followed by FOLFIRINOX induction chemotherapy in locally advanced pancreatic cancer (NEOLAP-AIO-PAK-0113): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):128-138. doi: 10.1016/S2468-1253(20)30330-7. Epub 2020 Dec 16.

    PMID: 33338442DERIVED

Related Links

Study Officials

  • Kunzmann Volker, Prof. Dr.

    Universitätsklinikum Würzburg/Comprehensive Cancer Center Mainfranken

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 29, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2019

Study Completion

February 19, 2020

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations

DE(1)