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

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

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

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Colon Cancer
• Intervention / Treatment: Combination product: CAPECITABINE AND OXALIPLATIN

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.

• Study Type: Interventional
• Enrollment (Anticipated): 238
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jorge Arredondo, DR.; Phone Number: +34 987237400; Email: jarredondo@outlook.es
• Study Contact Backup: Name: Pilar De la Torre; Phone Number: +34 987237400; Email: ptorref.asitec@saludcastillayleon.es

Study Locations

• Spain
  • León, Spain, 24071
    • Recruiting
    • Complejo Asistencial Universitario de León
    • Contact: Jorge Arredondo, DR.; Phone Number: +34 987237400; Email: jarredondo@outlook.es
    • Contact: Pilar De la Torre; Phone Number: +34 987237400; Email: ptorref.asitec@saludcastillayleon.es
    • Principal Investigator: Jorge Arredondo, Dr.
    • Sub-Investigator: Carmen Castañón, Dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
  3. No metastatic involvement in other organs (M0).
  4. Radiologically resectable disease. REFERENCES TO THE TREATMENT
  1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 3 cycles XELOX + Surgery+ 5 cycles XELOX	Combination product: CAPECITABINE AND OXALIPLATIN; Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)
Other: Control group; Surgery + 8 cycles XELOX	Combination product: CAPECITABINE AND OXALIPLATIN; Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (SLE) at 2 years	To determine whether the proposed treatment with neoadjuvant chemotherapy, surgery and complementary chemotherapy increases the disease-free survival (SLE) at 2 years postoperatively, compared with standard treatment, surgery and complementary chemotherapy.	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases SLE 5 years postoperatively, compared to standard treatment of surgery and complementary chemotherapy	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
To evaluate whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increase OS at 2 and 5 years postoperatively, in comparison with standard treatment of surgery and complementary chemotherapy.	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
To compare the postoperative morbidity and mortality of the neoadjuvant treatment in relation to the standard treatment	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.	From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Collaborators and Investigators

• Sponsor: Universidad de León
• Investigators: Principal Investigator: JORGE ARREDONDO, DR., Complejo Asistencial Universitario de León

Publications and helpful links

Helpful Links

• Spanish Registry of Clinical Studies

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Anticipated): May 10, 2023
• Study Completion (Anticipated): March 10, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: Nº AEMPS: 16-0553; 2016-002970-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No