Status:
UNKNOWN
Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors
Lead Sponsor:
Instituto de investigación e innovación biomédica de Cádiz
Conditions:
Pancreatic Adenocarcinoma
Pancreatic Cancer Resectable
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Resectable Pancreatic Cancer represents an important health problem not because of its incidence, but because of its high mortality. Diagnosis in the initial stages is difficult, since the first sympt...
Detailed Description
Disease: Pancreatic cancer resectable plus risk factors Hypothesis: The overall survival in patients treated with neoadjuvant chemotherapy before surgery -resection- plus adjuvant chemotherapy is hig...
Eligibility Criteria
Inclusion
- 1\. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
- 2\. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
- 3\. Patients who have not received prior therapy for pancreatic cancer.
- 4\. Biliary drainage prior to neoadjuvant treatment.
- 5\. Age\> 18 years and \<70 years.
- 6\. No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6 months prior to neoadjuvant treatment.
- 7\. Women of childbearing potential and sexually active men must agree to the use of appropriate contraceptive methods (hormonal, barrier, or abstinence) prior to study enrollment and during study participation.
- 8\. Patients should have normal organs and spinal function.
- 9\. Ability to understand, and willingness to sign a written informed consent document
Exclusion
- 1\. Patients with resectable pancreatic adenocarcinoma without risk factors.
- 2\. Patients with borderline pancreatic adenocarcinoma.
- 3\. Patients with locally advanced pancreatic adenocarcinoma.
- 4\. Patients with metastatic adenocarcinoma of the pancreas.
- 5\. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
- 6\. Pathological subtypes other than adenocarcinoma.
- 7\. Patients included in a clinical trial in a period of 6 months prior to inclusion in this study.
- 8\. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition.
- 9\. Uncontrolled breakthrough disease.
- 10\. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy.
- 11\. Other active malignancies
- 12\. Pre-existing neuropathy, grade \> 1.
- 13\. Inflammatory bowel disease that is not controlled, or under current active therapy.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05181605
Start Date
April 15 2022
End Date
December 1 2024
Last Update
August 9 2022
Active Locations (1)
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1
Hospital Puerta del Mar
Cadiz, Spain, 11010