Survival analysis after pre-surgical therapy in patients with resectable pancreatic cancer and risk factors
- Conditions
- Resectable pancreatic cancer and risk factorsMedDRA version: 21.0Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000317-17-ES
- Lead Sponsor
- Fundación para la Gestión de la Investigación Biomédica de Cádiz-INIBICA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 116
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.
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 116
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess overall survival in patients treated with neoadyuvant chemotherapy before surgery-resection and adyuvant chemotherapy vs patients traeted only with adjuvant chemotherapy after surgery-resection;Secondary Objective: To assess in both patients (experimental vs control arms):<br>- Progression free survival <br>- Number of completed cycles fo chemotherapy<br>- Local and metastatic recurrence<br>- Post-surgical morbidity<br>- Resection rate R0<br>- Safety of the neoadyuvant chemotherapy;Primary end point(s): Period (weeks) until death;Timepoint(s) of evaluation of this end point: Not applicable, since time is the endpoint of evaluation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Period (weeks) until recurrence disease (local or metastatic recurrence)<br>- Number of completed chemotherapy cycles<br>- development and location of new lesions <br>- Number and data about post-surgical events (if any)<br>- Resection rate RO<br>- Number and data about adverse events.;Timepoint(s) of evaluation of this end point: These data will be recordered along the follow up period of patients (since cycle 1- day 1 until the end of the follow up period)