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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Locally Advanced Pancreatic Adenocarcinoma Chemotherapy Effect Borderline Resectable Pancreatic Adenocarcinoma Pancreatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No