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NCT02919787 · CITED IN SOURCE DOCUMENTS

Nordic Pancreatic Cancer Trial (NorPACT) - 1

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2, PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2024-11-20

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Surgery and then postoperative adjuvant chemotherapy
    intervention Names
    1. Procedure: Pancreatic surgery
    2. Drug: 5-FU
    3. Drug: Oxaliplatine
    4. Drug: Irinotecan
    label
    Surgery and then postoperative adjuvant chemotherapy
    type
    ACTIVE_COMPARATOR
  2. description
    Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    intervention Names
    1. Drug: 5-FU
    2. Drug: Oxaliplatine
    3. Drug: Irinotecan
    4. Procedure: Pancreatic surgery
    label
    Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    description
    Neoadjuvant treatment
    name
    5-FU
    type
    DRUG
  2. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    description
    Neoadjuvant treatment
    name
    Oxaliplatine
    type
    DRUG
  3. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    description
    Neoadjuvant treatment
    name
    Irinotecan
    type
    DRUG
  4. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    2. Surgery and then postoperative adjuvant chemotherapy
    description
    All patients
    name
    Pancreatic surgery
    type
    PROCEDURE
  5. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    2. Surgery and then postoperative adjuvant chemotherapy
    description
    Adjuvant treatment
    name
    5-FU
    type
    DRUG
  6. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    2. Surgery and then postoperative adjuvant chemotherapy
    description
    Adjuvant treatment
    name
    Oxaliplatine
    type
    DRUG
  7. arm Group Labels
    1. Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    2. Surgery and then postoperative adjuvant chemotherapy
    description
    Adjuvant treatment
    name
    Irinotecan
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
140
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Overall survival at 18 months after date of randomization (intention to treat)
    measure
    Overall survival 18 month after randomization
    time Frame
    18 month
secondary Outcomes
  1. description
    Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection
    measure
    Overall mortality at one year following commencement of allocated treatment.
    time Frame
    1 year
  2. description
    Patient will come to regular after surgery for follow-up visits regarding their disease.
    measure
    Disease-free survival
    time Frame
    until 5 years after surgery
  3. description
    The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)
    measure
    Histopathological response
    time Frame
    Arm 1: Baseline and Arm 2; 4 weeks after baseline
  4. description
    Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems
    measure
    Complication rate after surgery
    time Frame
    30 and 90 days
  5. description
    The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay
    measure
    Feasibility of neoadjuvant and adjuvant chemotherapy
    time Frame
    Baseline
  6. description
    Data of quality of life will be assessed by the questionnaires EORTC QLQ-30
    measure
    Health related Quality of Life
    time Frame
    until 5 years after surgery
  7. description
    Data of quality of life will be assessed by the questionnaires EQ-5D
    measure
    Health economics
    time Frame
    until 5 years after surgery
Full study description
brief 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
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).
Source references
references
  1. citation
    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.
    pmid
    38237621
    type
    RESULT
  2. citation
    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.
    pmid
    28841916
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        PANC-3</a> (NCT04927780), <a href="/clinicaltrials/NCT02959879">PANACHE-01-PRODIGE</a> (NCT02959879), and <a href="/clinicaltrials/NCT02919787">NorPACT-01</a> (NCT02919787).</p></li></ol></div> </section> <section id="_126"> <h4 id="_126_toc">Surgery </h4> <p id="_1914" tabindex="-1"> Complete resectio
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      source title
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      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice