Oncoxin-Viusid/Stomach and gastric esophagus union cancer / Adults / Phase II

Phase 2

• Conditions: cancer of the stomach and gastric esophagus union.; Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Diseases; Stomach Diseases

• Registration Number: RPCEC00000272
• Lead Sponsor: aboratorios Catalysis, S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Patients with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme.
2. Patients of any sex with age = 18 years.
3. Patients with clinical status according to Karnofsky index = 70%.
4. Patients with life expectancy = 3 months.
5. Clinically fit patients to receive the FOLFOX chemotherapy scheme.
6. Patients who have signed informed consent for the investigation.
7. Patients with laboratory parameters within normal limits 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, platelet count> 100 x 109 / L, total bilirubin = 1.5 times the upper limit of the normal range established in the institution, TGO / TGP =2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution.
8. Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion Criteria

1. Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
2. Patients who are being treated with another product under investigation.
3. Patients with known hypersensitivity to any component of the investigational product.
4. Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
5. Patients with acute allergic states or history of severe allergic reactions.
6. Patients with acute, chronic, or inflammatory decompensated infectious diseases.
7. Patients with brain metastases.
8. Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
9. Patients in the period of breast-feeding or puerperium.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life. Measurement time: at baseline and, at a week after end of treatment. It will measured by:<br>- EORTC QLQ-C30 (score of every item and global score). <br>- EORTC EORTC QLQ-STO22 if gastric cancer (score of every item and global score). <br>- EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score).<br>- Karnofsky index (Score of 0-100 points at intervals of 10). <br>