NCT02047513

Brief Summary

NEONAX is an interventional, prospective, randomized, controlled, open label, two sided survival phase II studies against a fixed survival probability, with an unconnected analysis of the results in both experimental arms. Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post randomization

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

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

January 9, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

5.8 years

First QC Date

January 9, 2014

Last Update Submit

June 13, 2023

Conditions

Resectable Pancreatic CancerDuctal Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

  • Time to Disease free survival (DFS)

    To improve the DFS rate at 18 months in at least one arm to≥ 55%

    18 months after randomization

Secondary Outcomes (14)

  • Safety

    57 months

  • morbidity and mortality

    7 years

  • toxicity

    57 months

  • Disease progression

    7 years

  • resection rate

    53 months

  • +9 more secondary outcomes

Study Arms (2)

perioperative nab-paclitaxel/gemcitabine

EXPERIMENTAL

neoadjuvant chemotherapy (8 weeks) preceding surgery (3 weeks after completion of chemotherapy) followed by adjuvant chemotherapy (16 weeks, begin within 12 weeks after surgery)

Drug: perioperative nab-paclitaxel/gemcitabine

adjuvant nab-paclitaxel/gemcitabine

EXPERIMENTAL

Surgery followed by adjuvant chemotherapy (24 weeks, begin within 12 weeks after surgery), follow-up per patient: Until end of study or death

Drug: adjuvant nab-paclitaxel/gemcitabine

Interventions

perioperative nab-paclitaxel/gemcitabineDRUG

2 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles) followed by 3 weeks of rest and subsequent tumor surgery. Starting within 12 weeks after surgery adjuvant chemotherapy with 4 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles)

perioperative nab-paclitaxel/gemcitabine
adjuvant nab-paclitaxel/gemcitabineDRUG

Tumor surgery followed by adjuvant chemotherapy with 6 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles, starting within 12 weeks after surgery)

adjuvant nab-paclitaxel/gemcitabine

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytological confirmed, clearly resectable ductal adenocarcinoma of the pancreas (PDAC) ≤ cT3 with no prior tumor specific treatment.
  • No evidence of metastases to distant organs (e.g. liver, peritoneum, lung).
  • Resectable tumor. Determination of resectability based on spiral CT scans with both oral and i.v. contrast enhancement or on MRI using a recent consensus definition (Resectability: Clear fat planes around the celiac artery, hepatic artery and superior mesenteric artery.)
  • Measurable tumor according to RECIST 1.1
  • ECOG performance status 0 or 1
  • Creatinine clearance ≥ 30 ml/min
  • Serum total bilirubin level ≤ 2.5 x ULN (not necessary for enrollment or randomization, but before start of neoadjuvant chemotherapy in arm A)
  • ALT and AST ≤ 2.5 x ULN (not necessary for enrollment or randomization, but before start of neoadjuvant chemotherapy in arm A)
  • In case of biliary obstruction, biliary decompression is required if the patient was randomized to receive neoadjuvant chemotherapy (arm A)
  • White blood cell count ≥ 3.5 x 106/ml, neutrophil granulocytes count ≥ 1,5 x 106/ml, platelet count ≥ 100 x 106/ml
  • Signed informed consent incl. participation in translational research
  • Age ≥ 18 years

You may not qualify if:

  • Borderline resectable PDAC by radiologic criteria
  • Papillary cancer
  • Neuroendocrine Cancer
  • Tumor specific pre-treatment
  • Local recurrence
  • Peritoneal or other distant metastases
  • Radiographic evidence of severe portal hypertension/cavernous transformation
  • Infiltration of extrapancreatic organs (except duodenum)
  • Ascites
  • Gastric outlet obstruction
  • Global respiratory insufficiency requiring oxygen supplementation
  • Chronic infectious diseases, immune deficiency syndromes
  • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
  • Disability to understand and sign written informed consent document
  • Past or current history of malignancies except for the indication under this study and curatively treated:
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm, Dept. of Internal Medicine I

Ulm, 89081, Germany

Location

Related Publications (2)

  • Seufferlein T, Uhl W, Kornmann M, Algul H, Friess H, Konig A, Ghadimi M, Gallmeier E, Bartsch DK, Lutz MP, Metzger R, Wille K, Gerdes B, Schimanski CC, Graupe F, Kunzmann V, Klein I, Geissler M, Staib L, Waldschmidt D, Bruns C, Wittel U, Fichtner-Feigl S, Daum S, Hinke A, Blome L, Tannapfel A, Kleger A, Berger AW, Kestler AMR, Schuhbaur JS, Perkhofer L, Tempero M, Reinacher-Schick AC, Ettrich TJ. Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group. Ann Oncol. 2023 Jan;34(1):91-100. doi: 10.1016/j.annonc.2022.09.161. Epub 2022 Oct 7.

    PMID: 36209981DERIVED

  • Ettrich TJ, Berger AW, Perkhofer L, Daum S, Konig A, Dickhut A, Wittel U, Wille K, Geissler M, Algul H, Gallmeier E, Atzpodien J, Kornmann M, Muche R, Prasnikar N, Tannapfel A, Reinacher-Schick A, Uhl W, Seufferlein T. Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. BMC Cancer. 2018 Dec 29;18(1):1298. doi: 10.1186/s12885-018-5183-y.

    PMID: 30594153DERIVED

Related Links

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Thomas Seufferlein, Prof. Dr.

    University of Ulm, Dept. of Internal Medicine I

    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

January 9, 2014

First Posted

January 28, 2014

Study Start

July 1, 2015

Primary Completion

April 1, 2021

Study Completion

October 1, 2022

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

DE(1)