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Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423731
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Helse Stavanger HF
Information provided by (Responsible Party):
Knut Jørgen Labori, Oslo University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Locally Advanced Pancreatic Adenocarcinoma Chemotherapy Effect Borderline Resectable Pancreatic Adenocarcinoma Pancreatectomy Drug: Folfirinox

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Folfirinox
    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 Outcome Measures :
  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 Outcome Measures :
  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)

    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Population based cohort from a universal health care system
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423731


Contacts
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Contact: Knut J. Labori, MD, PhD +4723070000 uxknab@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0268
Contact: Knut J. Labori, MD, PhD    +4723070000    uxknab@us-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Helse Stavanger HF
Investigators
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Principal Investigator: Knut J. Labori, MD, PhD Oslo University Hospital, Oslo, Norway
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Responsible Party: Knut Jørgen Labori, Consultant surgeon MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04423731    
Other Study ID Numbers: 2017/1382/REK nord
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Gemcitabine
Paclitaxel
Fluorouracil
Folfirinox
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients