Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA) (ELECLA)
Locally Advanced Colon Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Colon Cancer
Eligibility Criteria
Inclusion Criteria:
CLINICS
- Histological confirmation of colon adenocarcinoma.
- Patients of both sexes with age over 18 years.
- Good general condition of the patient (Karnofsky> 60% or ECOG (Eastern Cooperative Oncology Group) <2).
- Analytical at the time of inclusion with figures of Hemoglobin> 10 g / dL; Leukocytes> 3.0 109 / L, Platelets> 100,000, Glomerular Filtration> 50 ml / min and Total Bilirubin <25 micromol / l.
- Absence of contraindication for chemotherapy.
- Acceptance and signature of the Informed Consent.
OF IMAGE
- Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration> 5 mm of transmural invasion.
- With or without lymph node involvement by CT.
- No metastatic involvement in other organs (M0).
- Radiologically resectable disease. REFERENCES TO THE TREATMENT
- That they will undergo elective surgery with curative intent (R0).
Exclusion Criteria:
1. Important comorbidity, uncontrolled angina or a history of acute myocardial infarction in the last 6 months.
2. Personal history of another malignancy in the last 5 years, with the exception of melanoma.
3. Uncontrolled infection 4. Pregnancy or lactation. 5. Peripheral neuropathy> grade 1. 6. Rectum cancer (<15 cm of the anal margin or below peritoneal reflection). 7. Presence of distant metastasis or peritoneal carcinomatosis. 8. Intestinal obstruction. 9. Existence of microsatellite instability 10. Refusal to participate or to give written consent 11. Impossibility, at the investigator's discretion, to understand the purpose of the study or to comply with its procedures.
Sites / Locations
- Complejo Asistencial Universitario de LeonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Intervention Group
Control group
3 cycles XELOX + Surgery+ 5 cycles XELOX
Surgery + 8 cycles XELOX