NCT04423731Active, not recruiting
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study (NORPACT-2)
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 251 (actual)
- First submitted
- 4 Jun 2020
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- Oslo University Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT04423731
What you commit to
- Study type: Observational
- Participants enrolled: 251
- From 1 Jan 2018 to the primary completion date, 31 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- mental or physical disorders that could interfere with treatment of with the provision of informed consent
Lab values
- 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
Age
- female patients in child-bearing age not using adequate contraception, pregnant or lactating women
Other
- co-morbidity precluding pancreatectomy
- chronic neuropathy ≥ grade 2
- WHO performance score \> 2
- any reason why, in the opinion of the investigator, the patient should not participate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.