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”

Phase 1

• Conditions: Patients with non-resectable or resectable pancreatic cancer; MedDRA version: 14.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000703-40-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-21
• Study Completion: 2016-02-15
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 53

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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.
a.Unstable angina or myocardial infarction within 12 months
b.NYHA class III & IV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the trial is to evaluate the effect of FOLFIRINOX in combination with chemo-radiotherapy in patients with borderline resectable pancreatic cancer (stage II or III).<br> <br>Primary objective:<br>- 2 year survival <br>;Secondary Objective: Secundary endpoints:<br>- Resection rate<br>- Progression free survival<br>- Response rate<br>- Toxicity;Primary end point(s): The objective of the trial is to evaluate the effect of FOLFIRINOX in combination with chemo-radiotherapy in patients with borderline resectable pancreatic cancer (stage II or III).<br> <br>Primary objective:<br>- 2 year survival<br>;Timepoint(s) of evaluation of this end point: Within 2 years after end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secundary endpoints:<br>- Resection rate<br>- Progression free survival<br>- Response rate<br>- Toxicity<br>;Timepoint(s) of evaluation of this end point: Within 2 years after completion of the study