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. |