Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA)

Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced

NCT04188158•Universidad de León

View on ClinicalTrials.gov

Summary

Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial

Detailed Description

Participants in this study selected patients according to homogeneous inclusion criteria and will be treated either with a uniform protocol of neoadjuvant chemotherapy, surgery and complementary chemotherapy (intervention group), or with the standard scheme of postoperative surgery and chemotherapy (control group ). All patients will be studied basally through clinical examinations and radiological and endoscopic tests usually used to reach the diagnosis of Locally Advanced Colon Cancer . In the group of patients receiving neoadjuvant treatment, the CT scan will be repeated after the completion of preoperative chemotherapy to restage the disease and quantify the degree of tumor response. Finally, the project tries to determine whether the neoadjuvant treatment scheme increases disease-free survival (SLE) at 2 and 5 years and overall survival (OS) at 5 years. Likewise, the toxicity derived from chemotherapy treatment and perioperative morbidity and mortality will be analyzed to evaluate the feasibility and safety of the therapeutic procedure. The rate of completion of chemotherapy in both groups will also be compared.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•CLINICS
•1. Histological confirmation of colon adenocarcinoma.
•2. Patients of both sexes with age over 18 years.
•3. Good general condition of the patient (Karnofsky\> 60% or ECOG (Eastern Cooperative Oncology Group) \<2).
•4. 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.
•5. Absence of contraindication for chemotherapy.
•6. Acceptance and signature of the Informed Consent.
•OF IMAGE
•1. Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration\> 5 mm of transmural invasion.
•2. With or without lymph node involvement by CT.
+4 more criteria

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.

Locations (1)

Complejo Asistencial Universitario de Leon

León, Spain

Key Dates

Start Date

March 10, 2017

Primary Completion Date

May 10, 2023

Completion Date

March 10, 2024

Last Updated

December 5, 2019

Enrollment

238

ESTIMATED participants

Conditions

Locally Advanced Colon Cancer

Interventions

CAPECITABINE AND OXALIPLATIN

COMBINATION_PRODUCT

Contacts

JORGE ARREDONDO, DR.

CONTACT

+34 987237400 jarredondo@outlook.es

PILAR DE LA TORRE

CONTACT

+34 987237400 ptorref.asitec@saludcastillayleon.es