ELECLA: Analysis of effectiveness of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer.

Trial Overview

Acronym	ELECLA
Number	EudraCT number: 2016-002970-10. AEMPS number: AEMPS: 16-0553.
Protocol Link	https://reec.aemps.es/reec/public/detail.html
Public Trial Registry Link	https://reec.aemps.es/reec/public/detail.html
Status	Open/recruiting
Category	Colorectal Cancer - Colonic Specific
Treatment Course	Neoadjuvant

Trial Description

Current standard therapy for locally advanced colon cancer (LACC) is based on surgery followed by adjuvant chemotherapy. It is proposed a clinical trial to determine, on one hand, if neoadjuvant therapy in LACC patients achieves clinical and pathologic tumour response, and on the other hand, to assess if this therapeutic sequence translates into a survival benefit, without increasing morbi-mortality. Patients will be included according to homogeneous inclusion criteria, and will be treated homog

Chief Investigator

M.D. Ph.D Jorge Arredondo Chaves
M.D. Ph.D.

Profile Link

Lead Centre

Hospital de León
Altos de Navas
León
24009
Spain

Website

Collaboration and Funding

Collaborative Sites

1. Hospital Gómez Ulla, Madrid
Glorieta del Ejercito, 1
Madrid
28047
Spain
Contact: Patricia Tejedor
Website

2. Hospital Universitario de Burgos
Glorieta del Ejercito, 1
Madrid
28047
Spain
Contact: Ana López
Website

3. Hospital Universitario Álvaro Cunqueiro, Vigo
Camiño Dos Cañotais 44
Vigo
36204
Spain
Contact: Vincenzo Vigorita
Website

4. Hospital Universitario Son Llàtzer
Manacor Highway, Km 4,
Palma de Mallorca
07198
Mallorca, Balearic Islands
Contact: Marta Tasende
Website

5. Hospital Universitario Lucus Augusti, Lugo
Dr. Ulises Romero, 1
Lugo
27003
Spain
Contact: Manuel Muinelo
Website

6. Hospital Universitario Central de Asturias, Oviedo
Roma Avenue, 33011
Oviedo
33011
Spain
Contact: Luis García Flórez
Website

7. Hospital Universitario de Badajoz
Elvas avenue
Badajoz
06080
Spain
Contact: Isabel Gallarín
Website

8. Hospital Universitario Nuestra Señora del Prado, Talavera de la Reina
Madrid Road, 114
Talavera de la Reina
45600
Spain
Contact: Felipe García
Website

9. Hospital Universitario Virgen de la Arrixaca, Murcia
Madrid-Cartagena Road
El Palmar
30120
Spain
Contact: José Gil
Website

10. Hospital Universitario La Paz, Madrid
Castellana Avenue, 261
Madrid
28046
Spain
Contact: Isabel Prieto
Website

11. Clínica Universidad de Navarra, Madrid
Calle del Marquesado de Santa Marta 1
Madrid
28027
Spain
Contact: Carlos Pastor
Website

12. Clínica Universidad de Navarra, Pamplona
Pio XII Avenue, 36
Pamplona
31008
Spain
Contact: Jorge Baixauli
Website

13. Hospital Universitario Río Hortega, Valladolid
La Dulzaina street, 2
Valladolid
47012
Spain
Contact: Paloma Rodríguez
Website

14. Hospital Universitario Infanta Leonor, Madrid
AVENIDA GRAN VIA DEL ESTE 80
Madrid
28031
Spain
Contact: Alicia Ruiz de la Hermosa
Website

15. Hospital Universitario de León
Altos de Nava Street
León
24071
Spain
Contact: Jorge Arredondo
Website

Additional Information

Full Research Summary

Objective:	Neoadjuvant chemotherapy is being tested as an alternative for the treatment of locally advanced colon cancer (LACC).
Aim:	Assess if neoadjuvant chemotherapy in LACC achieves tumour response and improves DFS and OS when compared to standard therapy. Assess differences in morbidity and compliance rate between groups.
Methods:	Randomized, open-label, controlled trial. Experimental arm: Preoperative XELOX (capecitabine 1000 mg/m2 days 1-14 and oxaliplatin 130 mg/m2 on day one) each 21 days for 3 cycles followed by surgery (3-4 weeks after) and followed by XELOX for 5 cycles. Control arm: Surgery followed by XELOX for 8 cycles. Inclusion criteria: Histological confirmation of adenocarcinoma. > 18 years. ECOG 0 -1. Colon cancer classified as T4 or T3 with extramural depth > 5mm by CT scan. Written informed consent. Exclusion criteria: Distant metastases. Emergency surgery. Contraindication for chemotherapy. Previous cancer in the last 5 years. Primary and secondary outcome parameters: DFS. OS. Surgical morbidity. Toxicity. Compliance rate. Radiologic response. Pathological response.
Reason for International Trial:	To include other hospitals to be able to find significant differences between groups.

Trial Details

ELECLA: Analysis of effectiveness of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer.

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

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Trial Details

ELECLA: Analysis of effectiveness of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer.

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

About ESCP

News & Events

Education

Research

Members

Contact Us

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