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Pancreatic NeoplasmsTRUSTNCT02670746

A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer

An observational study of Pancreatic Neoplasms, run by Celgene at 18 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
How many people
44 participants
Where
18 sitesNetherlands
Study dates
1 Oct 2015to 28 Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Two-hundred adult patients treated with the combination nab-paclitaxel and gemcitabine (AG) for metastatic pancreatic adenocarcinoma will be recruited from approximately 25 oncology sites in the Netherlands. In all cases, the decision to treat the patient with AG was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per SmPC.

Who may be able to join

  • Patients over 18 years of age who understand and voluntarily sign an informed consent form.
  • Patients treated for pancreatic adenocarcinoma.

Who cannot join

  • Patients currently treated for metastatic pancreatic cancer with other therapy than nab-paclitaxel plus gemcitabine
  • Refusal to participate in the study.
  • Women who are pregnant or breast-feeding.
  • Hypersensitivity to the active substance or to any of the excipients.
  • Participation in interventional trials during the period of treatment with nab-paclitaxel

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Netherlands18 sites

  • BovenIJ Ziekenhuis

    Amsterdam, North Holland, 1034 CS

  • Academic Medical Centre

    Amsterdam, North Holland, 1105 AZ

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland, 6815 A

  • Amphia ziekenhuis

    Breda, Gelderland, 4818 CK

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland, 3328 AT

  • Gelderse Vallei

    Ede, North Brabant, 2545 CH

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Spaarne Gasthuis

    Haarlem, North Holland, 2035 RC

  • Ziekenhuis de Tjongerschans

    Heerenveen, Provincie Friesland, 8841 PW

  • Elkerliek Ziekenhuis

    Helmond, North Brabant, 5707 HA

  • Tergooi

    Hilversum, North Holland, 1213XZ

  • LUMC

    Leiden, South Holland, 2333 ZA

  • Antonius Ziekenhuis Sneek

    Sneek, Provincie Friesland, 8601 ZK

  • Zorgsaam Zeeuws -Vlaanderen

    Terneuzen, Zeeland, 4535 PA

  • HagaZiekenhuis

    The Hague, South Holland, 2545 CH

  • UMC Utrecht

    Utrecht, 3584 CX

  • Maxima Medisch Centrum

    Veldhoven, North Brabant, 5504 DB

  • Isala

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

About this study

Official title: Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)

The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.

Read the detailed description

The TRUST, a prospective, non-interventional observational single arm study with Nab-paclitaxel + Gemcitabine (NG) in pancreas carcinoma in the Netherlands, was started in 2015 to observe and register the daily use of Nab-paclitaxel. The primary objective was to prospectively assess safety of NG in metastatic pancreatic cancer under routine clinical practice. One of the major secondary objectives was to assess the influence of treatment with Nab-paclitaxel + Gemcitabine on the quality of life. The goal was to include 200 patients within a period of two year and collect their prospective data.

The study has included 44 patients in the period between October 2015 and October 2017. Of these patients, 41% were diagnosed with metastasized disease. 54% was diagnosed with local disease of which 18% was resectable and 36% was locally advanced. 73% of the patients with metastasized disease were treated with NG.

Over 70% of all NG treated patients received this treatment as a fist line of care. 21% of these patients had locally advanced pancreatic cancer. 20% of the patients had had a previous systemic treatment. Of all NG treated patients, 66% had an ECOG performance status of 0 or 1 and 62% of the patients was 75 years or younger.

At the time the study was terminated, 6 out of the 44 patients were still treated. 14 patients had stopped treatment due to disease progression, 8 patients had stopped due to adverse events and 7 patients had chosen to stop treatment.

The low inclusion rate, which led to a prospective study duration of 10 years, and the heterogenicity of the study population have led to the decision to terminate the study. Therefore, no analysis, apart from the detailed description of the study population above, can be performed.

All patients involved have taken the time to participate in the study and have filled out questionnaires. We would like to express our gratitude towards these patients.

We remain convinced that quality of life is an important parameter in pancreatic cancer which should be taken into consideration in daily care of patients.

Keywords
Pancreatic Cancer, Observational, Nab-Paclitaxel, Abraxane, ABI-007, Gemcitabine, Non-interventional, Netherlands, Quality of Life
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02670746
Study groupRoleWhat they receive
Nab-paclitaxel in combination with gemcitabine (AG)The objective is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma. In all cases, the decision to treat the patient with nab-paclitaxel in combination with gemcitabine was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per Summary of Product Characteristics (SPC).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Survival is defined as the time from the first dose of nab-paclitaxel in combination with gemcitabine date to the date of death (any cause).

    Measured: Up to approximately 3 years

  2. Adverse Event (AE)

    Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible.

    Measured: Up to approximately 3 years

Secondary outcomes (6)

  1. Change from baseline in the EORTC-QLQ-CIPN-20 (European Organization for Research and Treatment of Cancer Quality of Life Instrument In Patients With Chemotherapy Induced Peripheral Neuropathy )

    The instrument contains 20 questions evaluating sensory, motor, and autonomic symptoms, and has been validated as an assessment tool for CIPN. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.

    Measured: up to approximately 3 years

  2. Change from baseline in the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Instrument)

    The instrument contains 30 questions evaluating quality of life in cancer patients.

    Measured: up to approximately 3 years

  3. Change from baseline in the EuroQuality of Life : EQ5D-3L

    A generic Quality of Life (QOL) instrument to measure and evaluate health status outcomes. The 3 Level (3L) version describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem).

    Measured: up to approximately 3 years

  4. Evaluate the incidence of neuropathy - grade 1-5

    Descriptive analysis of incidence and severity of neuropathy according to physicians assessment

    Measured: up to approximately 3 years

  5. Evaluate reversibility of neuropathy to Gr ≤1

    The time to decrease of neuropathy to Gr ≤1 using the NCI CTCAE grading scale.

    Measured: up to approximately 3 years

  6. Evaluate the resources utilized for treatment of pancreatic adenocarcinoma with the combination nab-paclitaxel/gemcitabine in routine clinical practice

    Per hospital, one generalized questionnaire will be filled in to evaluate the use of utilized resources when treating metastatic pancreatic cancer within routine clinical practice.

    Measured: up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion28 Nov 2017
  4. Study completion28 Nov 2017

Why it stopped: Due to slow recruitment study is being terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670746
Sponsor's protocol ID
ABI-007-PANC-008
Acronym
TRUST
Status last verified
Sep 2019
First submitted
31 Aug 2015
Last updated
16 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.

    PubMed 30149366

  • Vogl DT, Raje N, Jagannath S, Richardson P, Hari P, Orlowski R, Supko JG, Tamang D, Yang M, Jones SS, Wheeler C, Markelewicz RJ, Lonial S. Ricolinostat, the First Selective Histone Deacetylase 6 Inhibitor, in Combination with Bortezomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2017 Jul 1;23(13):3307-3315. doi: 10.1158/1078-0432.CCR-16-2526. Epub 2017 Jan 4.

    PubMed 28053023

  • Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12.

    PubMed 30209750

  • Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x.

    PubMed 29946913

  • Pelzer U, Wislocka L, Juhling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4.

    PubMed 30014884

  • Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

    PubMed 29932294

  • Neumann CCM, von Horschelmann E, Reutzel-Selke A, Seidel E, Sauer IM, Pratschke J, Bahra M, Schmuck RB. Tumor-stromal cross-talk modulating the therapeutic response in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2018 Oct;17(5):461-472. doi: 10.1016/j.hbpd.2018.09.004. Epub 2018 Sep 7.

    PubMed 30243879

  • Veenstra VL, Damhofer H, Waasdorp C, van Rijssen LB, van de Vijver MJ, Dijk F, Wilmink HW, Besselink MG, Busch OR, Chang DK, Bailey PJ, Biankin AV, Kocher HM, Medema JP, Li JS, Jiang R, Pierce DW, van Laarhoven HWM, Bijlsma MF. ADAM12 is a circulating marker for stromal activation in pancreatic cancer and predicts response to chemotherapy. Oncogenesis. 2018 Nov 16;7(11):87. doi: 10.1038/s41389-018-0096-9.

    PubMed 30442938

  • Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

    PubMed 30497432

  • Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.

    PubMed 30006989

  • Barnes JA, Ellis ML, Hwang S, Emarine J, Merwin P, Salinas GD, Musher BL. Identification of Educational Gaps Among Oncologists Who Manage Patients with Pancreatic Cancer. J Gastrointest Cancer. 2019 Mar;50(1):84-90. doi: 10.1007/s12029-017-0033-8.

    PubMed 29177608

  • Woo W, Carey ET, Choi M. Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther. 2019 Feb 21;12:1455-1463. doi: 10.2147/OTT.S167590. eCollection 2019.

    PubMed 30863113

  • Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

    PubMed 30768369

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Neoplasms, run by Celgene at 18 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to slow recruitment study is being terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670746, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.

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