EUCTR2011-000703-40-DK
Active, not recruiting
Phase 1
Clinical trial with chemotherapy for patients with non-resectable, locally advanced pancreatic cancer and addition of chemo-radiotherapy for patients with borderline resectable pancreatic cancer. DPSG - ”Danish Pancreatic cancer Study Group” - Folfirinox
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Odense University Hospital
- Enrollment
- 53
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with histologically/cytologically proven pancreatic adenocarcinoma .
- •a.Patients can be included with appearance of malignant tumor cells at the cytological investigation or íf the investigator concludes that there is no indication for further biopsies.
- •2\. UICC stadium IIA/IIB or III.
- •3\. No lymphnode metastases outside the loco\-regional area. That is what is expected to be removed by surgical resection.
- •4\. 4\.Patients with measurable or non\-measurable disease according to RECIST version 1\.1\.
- •5\. Performance status 0 and 1\.
- •6\. Normal liver function with bilirubin \< 1\.5 x upper normal limit (UNL).
- •7\. Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\. Major surgery within 4 weeks.
- •a. Including laparatomy
- •2\. Other active malignant disease within the last 2 years.
- •3\. Previous anti\-neoplastic treatment for pancreatic cancer.
- •4\. Previous radiotherapy to the abdomen which influence the specific radiation dose in the protocol.
- •5\. Patients who are unable to follow treatment and evaluation plan.
- •6\. Any condition or therapy which after the opinion of the investigator exposes the patient to a risk or interfere with the purpose of the trial.
- •7\. Pregnant or lactating women.. In fertile women, this is done with a negative pregnancy test or use of safe anti\-contraception (the pill) during the last 3 months before inclusion. Patients of childbearing potential must use effective anti\-contraception (the pill) throughout the study treatment and at least 3 months after completion of study treatment.
- •8\. Known hypersensitivity towards one of the components in the treatment.
- •9\. Severe comorbidity.
Outcomes
Primary Outcomes
Not specified
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