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NCT Number: NCT04423731

Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (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.

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Key information

Conditions

Locally Advanced Pancreatic Adenocarcinoma Borderline Resectable Pancreatic Adenocarcinoma Chemotherapy Effect Pancreatectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0268, Norway

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Folfirinox

Drug

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.

Other names: Gemcitabine/nab-paclitaxel, Gemcitabine, 5-FU (fluorouracil) and leucovorin, FLOX

Primary outcomes

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

    Time frame: 5 years

    Patients who undergo surgical resection will be documented

Secondary outcomes

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

    Time frame: 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

    Time frame: 1 year after inclusion

  3. Overall survival following resection

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

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

    Time frame: 1, 2, 3 and 5 years after inclusion

  5. 1-year progression-free survival rate

    Time frame: 1-year after surgical resection

  6. Disease-free survival

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

  7. Radiological response

    Time frame: 2-6 months after initiation of chemotherapy

  8. Histopathological response

    Time frame: 14-30 days post surgery

  9. R0 resection rate

    Time frame: 14-30 days post surgery

  10. Complication rates after surgery classification systems)

    Time frame: 30 and 90 days post surgery

    Dindo-Clavien and ISPGS

  11. Completion rates of all parts of multimodal treatment

    Time frame: Up to 1 year after inclusion

  12. QoL (EORTC QLQ-30)

    Time frame: 5 years

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

    Time frame: 5 years

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

    • - 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)
    • - 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)
    • - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
    • - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Jun 9, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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