The (cost)effectiveness of preoperative chemotherapy versus preoperative gemcitabine based chemoradiotherapy and adjuvant gemcitabine in patients with pancreatic cancer.

Phase 1

• Conditions: (borderline) resectable pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002036-17-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-19
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

•Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
•(Borderline) resectable tumor without metastatic disease* (see table 1 for definitions of resectability)
•WHO performance status 0 or 1
•Ability to undergo surgery, chemoradiotherapy and chemotherapy**
•Leucocytes (WBC) = 3.0 X 109/l
•Platelets = 100X 109 /l
•Hemoglobin = 6 mmol/l
•Renal function: E-GFR = 50 ml/min
•Age = 18 years
•Written 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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

•Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
•Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX
•Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 53 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
•Pregnancy.
•Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Study & Design

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