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Locally Advanced Pancreatic AdenocarcinomaNCT04423731

Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)

An observational study of Locally Advanced Pancreatic Adenocarcinoma and Chemotherapy Effect, run by Oslo University Hospital at 1 site in Norway.

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 is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Folfirinox
How many people
251 participants
Where
1 siteNorway
Study dates
1 Jan 2018to 31 Dec 2025
Phase
Observational
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
  • Adult, Older adult

Study population: Population based cohort from a universal health care system

Who may be able to join

  • borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)
  • Nx, M0 (UICC 8 th version, 2016)
  • cytological or histological 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 pancreatectomy
  • chronic neuropathy ≥ grade 2
  • WHO performance score > 2
  • granulocyte count < 1500 per cubic millimetre
  • platelet count < 100 000 per cubic millimetre
  • serum creatinine > 1.5 UNL (upper limit normal range)
Show all 10Show fewer
  • albumin < 2,5 g/dl
  • female patients in child-bearing age not using adequate contraception, pregnant or lactating women
  • mental or physical disorders that could interfere with treatment of with the provision of informed consent
  • any reason why, in the opinion of the investigator, the patient should not participate

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0268

Other trials in Norway

About this study

Official title: Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study (NORPACT-2)

This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up.

Being tested
Folfirinox

What participants receive

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

  • FolfirinoxDrug

    Also called Gemcitabine/nab-paclitaxel, Gemcitabine, 5-FU (fluorouracil) and leucovorin, FLOX

    Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist.

What is being measured

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

  1. Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)

    Patients who undergo surgical resection will be documented

    Measured: 5 years

Secondary outcomes (13)

  1. Overall survival from time of inclusion (intention to treat)

    Measured: Overall survival rate at 5 years using Kaplan-Meier survival analysis

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 1 year after inclusion

  3. Overall survival following resection

    Measured: Overall survival rate at 5 years using Kaplan-Meier survival analysis

  4. Overall survival after 1, 2, 3 and 5 years

    Measured: 1, 2, 3 and 5 years after inclusion

  5. 1-year progression-free survival rate

    Measured: 1-year after surgical resection

  6. Disease-free survival

    Measured: Disease-free survival at 5 years using Kaplan-Meier survival analysis

  7. Radiological response

    Measured: 2-6 months after initiation of chemotherapy

  8. Histopathological response

    Measured: 14-30 days post surgery

  9. R0 resection rate

    Measured: 14-30 days post surgery

  10. Complication rates after surgery classification systems)

    Dindo-Clavien and ISPGS

    Measured: 30 and 90 days post surgery

  11. Completion rates of all parts of multimodal treatment

    Measured: Up to 1 year after inclusion

  12. QoL (EORTC QLQ-30)

    Measured: 5 years

  13. Performance status - Eastern Cooperative Oncology Group (ECOG)

    0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)

    1. - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
    2. - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
    3. - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
    4. - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)

    Measured: 5 years

Timeline

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

  1. First posted9 Jun 2020
  2. Study start1 Jan 2018
  3. Primary completion31 Oct 2022
  4. Study completion31 Dec 2025 (estimated)

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
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04423731
Sponsor's protocol ID
2017/1382/REK nord
Status last verified
Nov 2024
First submitted
4 Jun 2020
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Farnes I, Lund-Iversen M, Aabakken L, Verbeke C, Labori KJ. Molecular testing for personalized therapy is underutilized in patients with borderline resectable and locally advanced pancreatic cancer - real world data from the NORPACT-2 study. Scand J Gastroenterol. 2024 Sep;59(9):1093-1096. doi: 10.1080/00365521.2024.2373115. Epub 2024 Jul 3.

    PubMed 38957079

  • Farnes I, Paulsen V, Verbeke CS, Tonnesen CJ, Aabakken L, Labori KJ. Performance and safety of diagnostic EUS FNA/FNB and therapeutic ERCP in patients with borderline resectable and locally advanced pancreatic cancer - results from a population-based, prospective cohort study. Scand J Gastroenterol. 2024 Apr;59(4):496-502. doi: 10.1080/00365521.2023.2290456. Epub 2023 Dec 21.

    PubMed 38126766

  • Farnes I, Kleive D, Verbeke CS, Aabakken L, Issa-Epe A, Smastuen MC, Fosby BV, Dueland S, Line PD, Labori KJ. Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2). BJS Open. 2023 Nov 1;7(6):zrad137. doi: 10.1093/bjsopen/zrad137.

    PubMed 38155512

Questions about this trial

What is this clinical trial studying?

An observational study of Locally Advanced Pancreatic Adenocarcinoma and Chemotherapy Effect, run by Oslo University Hospital at 1 site in Norway.

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 10 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 1 site in Norway. 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?

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?

Rate of resectability in both groups (borderline and locally advanced pancreatic cancer) (time frame: 5 years). 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 NCT04423731, which also lists 3 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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