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Pancreatic CancerPhase 2/3NCT02919787

Nordic Pancreatic Cancer Trial (NorPACT) - 1

A Phase 2/3 study testing 5-FU, Oxaliplatine and Irinotecan in people with Pancreatic Cancer, run by Oslo University Hospital at 13 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
5-FU, Oxaliplatine and Irinotecan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
13 sitesin 4 countries
Study dates
Sep 2016to 30 Apr 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Resectable adenocarcinoma of the pancreatic head
  • T1-3, Nx, M0 (UICC 7th version, 2010)
  • Cytologic or histologic confirmation of adenocarcinoma
  • Age > 18 year and considered fit for major surgery
  • Written informed consent
  • Considered able to receive the study specific chemotherapy

Who cannot join

  • Co-morbidity precluding pancreaticoduodenectomy
  • Chronic neuropathy ≥ grade 2
  • WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
  • Platelet count < 100 000 per cubic millimeter
  • Serum creatinine > 1.5 UNL (upper limit normal range)
  • Albumin < 2,5 g/dl
Show all 12Show fewer
  • Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
  • Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
  • Percutaneous tumor biopsy
  • Any reason why, in the opinion of the investigator, the patient should not participate
  • Pregnancy
  • Breastfeeding

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Sweden6 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Karolinska University Hospital

    Huddinge, 14157

  • Linköping University Hospital

    Linköping, 58185

  • Skåne University Hospital

    Lund

  • University Hospital of Umeå

    Umeå, 90737

  • Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

Norway5 sites

  • Haukeland University Hospital

    Bergen, 5021

  • Oslo University Hospital

    Oslo, Oslo, N- 0424

  • Stavanger University Hospital

    Stavanger, 4011

  • Tromsø University Hospital

    Stavanger, 9038

  • St. Olav University Hospital

    Trondheim, 7030

Other trials in Norway

Denmark1 site

  • Odense University Hospital

    Odense

Other trials in Denmark

Finland1 site

  • Helsinki University Hospital

    Helsinki, 00029

Other trials in Finland

About this study

Official title: Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Read the detailed description

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC).

Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear.

The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Being tested
5-FU, Oxaliplatine, Irinotecan, Pancreatic surgery
Keywords
Neoadjuvant treatment
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • 5-FUDrug

    Neoadjuvant treatment

  • OxaliplatineDrug

    Neoadjuvant treatment

  • IrinotecanDrug

    Neoadjuvant treatment

  • Pancreatic surgeryProcedure or surgery

    All patients

  • 5-FUDrug

    Adjuvant treatment

  • OxaliplatineDrug

    Adjuvant treatment

  • IrinotecanDrug

    Adjuvant treatment

Study groups in NCT02919787
Study groupRoleWhat they receive
Surgery and then postoperative adjuvant chemotherapyActive comparatorSurgery and then postoperative adjuvant chemotherapy
Receives: Procedure: Pancreatic surgery; Drug: 5-FU; Drug: Oxaliplatine; Drug: Irinotecan
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapyExperimentalNeoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Receives: Drug: 5-FU; Drug: Oxaliplatine; Drug: Irinotecan; Procedure: Pancreatic surgery

What is being measured

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

  1. Overall survival 18 month after randomization

    Overall survival at 18 months after date of randomization (intention to treat)

    Measured: 18 month

Secondary outcomes (7)

  1. Overall mortality at one year following commencement of allocated treatment.

    Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection

    Measured: 1 year

  2. Disease-free survival

    Patient will come to regular after surgery for follow-up visits regarding their disease.

    Measured: until 5 years after surgery

  3. Histopathological response

    The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)

    Measured: Arm 1: Baseline and Arm 2; 4 weeks after baseline

  4. Complication rate after surgery

    Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems

    Measured: 30 and 90 days

  5. Feasibility of neoadjuvant and adjuvant chemotherapy

    The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay

    Measured: Baseline

  6. Health related Quality of Life

    Data of quality of life will be assessed by the questionnaires EORTC QLQ-30

    Measured: until 5 years after surgery

  7. Health economics

    Data of quality of life will be assessed by the questionnaires EQ-5D

    Measured: until 5 years after surgery

Timeline

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

  1. First posted29 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion22 Dec 2022
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919787
Sponsor's protocol ID
NorPACT-1
Other IDs
2015-001635-21, 2015
Status last verified
Nov 2024
First submitted
14 Sep 2016
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Labori KJ, Bratlie SO, Andersson B, Angelsen JH, Biorserud C, Bjornsson B, Bringeland EA, Elander N, Garresori H, Gronbech JE, Haux J, Hemmingsson O, Liljefors MG, Myklebust TA, Nymo LS, Peltola K, Pfeiffer P, Sallinen V, Sandstrom P, Sparrelid E, Stenvold H, Soreide K, Tingstedt B, Verbeke C, Ohlund D, Klint L, Dueland S, Lassen K; Nordic Pancreatic Cancer Trial-1 study group. Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):205-217. doi: 10.1016/S2468-1253(23)00405-3. Epub 2024 Jan 15.

    PubMed 38237621

  • Labori KJ, Lassen K, Hoem D, Gronbech JE, Soreide JA, Mortensen K, Smaaland R, Sorbye H, Verbeke C, Dueland S. Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer (Norwegian Pancreatic Cancer Trial - 1 (NorPACT-1)) - study protocol for a national multicentre randomized controlled trial. BMC Surg. 2017 Aug 25;17(1):94. doi: 10.1186/s12893-017-0291-1.

    PubMed 28841916

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 5-FU, Oxaliplatine and Irinotecan in people with Pancreatic Cancer, run by Oslo University Hospital at 13 sites in 4 countries.

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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Sweden, Norway, Denmark, Finland. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 18 month after randomization (time frame: 18 month). 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 NCT02919787, which also lists 2 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 20 Nov 2024.

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