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Sponsors and Collaborators: |
Institut Català d'Oncologia Hoffmann-La Roche |
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Information provided by: | Institut Català d'Oncologia |
ClinicalTrials.gov Identifier: | NCT00847119 |
The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.
Condition | Intervention | Phase |
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Rectal Cancer |
Biological: Bevacizumab Drug: capecitabine (Xeloda) Radiation: Rectal Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE |
Estimated Enrollment: | 43 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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a: Experimental
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period. |
Biological: Bevacizumab
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Drug: capecitabine (Xeloda)
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
Radiation: Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, hepatic and renal function, defined as:
Exclusion Criteria:
No prior or concurrent significant medical conditions, including any of the following:
Contact: Margarita Garcia, Phd | +34.93.260.73.31 | mgarciamartin@iconcologia.net |
Contact: Ramon Salazar, Phd | +34.93.260.77.44 ext 3381 | ramonsalazar@iconcologia.net |
Spain, Barcelona | |
Institut Català d'Oncologia-L'Hospitalet | Recruiting |
L'Hospitalet del Llobregat, Barcelona, Spain, 08907 | |
Contact: Valentín Navarro +34.93.260.78.22 vnavarro@iconcologia.net | |
Principal Investigator: Margarita García, Phd | |
Principal Investigator: Ramón Salazar, Phd | |
Sub-Investigator: Mercedes Martinez | |
Sub-Investigator: Soler Gemma | |
Sub-Investigator: Aleydis Pisa | |
Sub-Investigator: Santos Cristina | |
Sub-Investigator: Maria Cambray, Phd | |
Sub-Investigator: Berta Laquente |
Principal Investigator: | Ramon Salazar, Phd | Institut Català d'Oncologia |
Study Chair: | Margarita Garcia, MD | Institut Català d'Oncologia |
Responsible Party: | Institut Català d´Oncologia (ICO) L'Hospitalet ( Dra. Margarita García Martín ) |
Study ID Numbers: | ML 20006. XEBERECTO/ICO/005, EudraCT number:2007-000456-13 |
Study First Received: | February 18, 2009 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00847119 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
rectum adenocarcinoma neoadjuvant bevacizumab capecitabine |
radiotherapy locally advanced resectable resectable locally advanced adenocarcinoma of the rectum |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colorectal Neoplasms |