Oncoxin-Viusid / Pancreatic adenocarcinoma / Adults / Phase II

Phase 2

• Conditions: Pancreatic cancer; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Diseases; Endocrine System Diseases

• Registration Number: RPCEC00000281
• Lead Sponsor: aboratories Catalysis, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1- Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
2- Patients that meet the diagnostic criteria.
3- Patients with general health according to Karnofsky =70%.
4- Life expectancy greater than or equal to 3 months.
5- Patients eligible to receive chemotherapy.
6- Patients who have signed the informed consent.
7- Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy: Hemoglobin = 90 g/l, Total Leukocyte Count = 3.0 x 109 / L, Absolute Neutrophil Count =1.5 x 109 / L. o Platelet count =100 x 109 / L, Total bilirubin values = 1.5 times the upper limit of the normal range established in the institution, TGO and TGP values =2.5 times the upper limit of the normal interval established in the institution and, Creatinine values within the normal limits of the institution.

Exclusion Criteria

1- Patients who are receiving another product under investigation.
2- Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used
3- Patients with decompensated intercurrent diseases, including: HBP, Diabetes Mellitus, Ischemic Heart Disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
4-Patients who are pregnant or breastfeeding.
5- Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
6- Patients with brain metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life (General Quality of Life EORTC QLQ-C30). Measurement time: at baseline and, 3, 6, 9, 12 months.