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| Sponsor: | Grupo Espanol Multidisciplinario del Cancer Digestivo |
|---|---|
| Collaborator: |
Royal Marsden NHS Foundation Trust |
| Information provided by: | Grupo Espanol Multidisciplinario del Cancer Digestivo |
| ClinicalTrials.gov Identifier: | NCT00909987 |
Purpose
Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectum Cancer |
Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab Radiation: Radiotherapy Drug: Capecitabine during all Radiotherapy period Procedure: Total Mesorectal Excision (TME) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging |
| Estimated Enrollment: | 46 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clinic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Joan Maurel, Dr 932275400 | |
| Principal Investigator: Joan Maurel, Oncologist | |
| Principal Investigator: Carles Conil, Radiotherapy | |
| Principal Investigator: Antonio Lacy, Surgeon | |
| Principal Investigator: Juan Ramón Ayuso, Radiologist | |
| Hospital Arnau de Vilanova | Recruiting |
| Lérida, Spain, 25198 | |
| Contact: Antonieta Salud, Oncologist 973248100 / 973705200 | |
| Principal Investigator: Antonieta Salud, Oncologist | |
| Principal Investigator: Moisés Miraflores, Radiotherapy | |
| Principal Investigator: Enrique Sierra Grañón, Surgeon | |
| Principal Investigator: Xavier matías-Guiu Guía, Pathologist | |
| Hospital La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Jaime Feliu, Dr. 917277000 | |
| Principal Investigator: Jaime Feliu, Oncologist | |
| Principal Investigator: María Elena Sánchez Santos, Radiotherapy | |
| Principal Investigator: Damián García Olmo, Surgeon | |
| Principal Investigator: Paula Alegría, Radiologist | |
| Hospital de Navarra | Recruiting |
| Pamplona, Spain, 31008 | |
| Contact: Ruth Vera, Oncologist 848422100 | |
| Principal Investigator: Ruth Vera, Oncologist | |
| Principal Investigator: Fernando Arias de la Vega, Radiotherapy | |
| Principal Investigator: Javier Suárez Alecha, Surgeon | |
| Principal Investigator: Javier Jiménez, Radiologist | |
| Principal Investigator: María Luisa Gómez, Pathologist | |
| Instituto Valenciano de Oncología (IVO) | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Carlos Fernández Martos, Oncologist cfmartos@fivo.org | |
| Principal Investigator: Carlos Fernández Martos, Oncologist | |
| Principal Investigator: José Luis Mengual, Radiotherapy | |
| Principal Investigator: Jorge Campos, Surgeon | |
| Principal Investigator: Jesús Santos, Radiologist | |
| Principal Investigator: Ana Calatrava, Pathologist | |
| Hospital La Fe | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Jorge Aparicio, Dr. 963862700 | |
| Principal Investigator: Jorge Aparicio, Oncologists | |
| Principal Investigator: Alejandro Tormo Micó, Radiotherapy | |
| Principal Investigator: Rafael Estevan, Surgeon | |
| Principal Investigator: Fernando Mas Estellés, Radiologist | |
| Principal Investigator: María José Artes, Pathologist | |
| Hospital General de Valencia | Recruiting |
| Valencia, Spain, 46014 | |
| Contact: María José Safont 961972000 | |
| Principal Investigator: María José Safont, Oncologist | |
| Principal Investigator: Ana Hernández Machancoses, Radiotherapy | |
| Principal Investigator: José Vicente Roig, Surgeon | |
| Principal Investigator: Vicente Martínez Sanjuán, Radiologist | |
| Principal Investigator: Encarna Martínez, Pathologist | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: Vicente Alonso, Oncologist 976765500 | |
| Principal Investigator: Vicente Alonso, Oncologist | |
| Principal Investigator: Martín Tejedor Gutierrez, Radiotherapy | |
| Principal Investigator: Andrés Monzón, Surgeon | |
| Principal Investigator: Luís Sarriá, Radiologist | |
| Principal Investigator: Carlos Hörndler, Pathologist | |
| Hospital Clínico Universitario Lozano Blesa | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: Pilar Escudero, Oncologist 976765700 | |
| Principal Investigator: Pilar Escudero, Oncologist | |
| Principal Investigator: Javier Valencia, Radiotherapy | |
| Principal Investigator: Eloy Tejero, Surgeon | |
| Principal Investigator: José Antonio Fernández Gómez, Radiologist | |
| Principal Investigator: Javier Ortego, Pathologist | |
| Spain, Barcelona | |
| Complejo Sanitario Parc Taulí | Recruiting |
| Sabadell, Barcelona, Spain, 08208 | |
| Contact: Carles Pericay, Oncologist 937231010 | |
| Principal Investigator: Carles Pericay, Oncologist | |
| Principal Investigator: Anna Darnell, Radiologist | |
| Principal Investigator: Alex Casalots Casado, Pathologist | |
| Study Chair: | Carlos Fernández Martos, Oncologist | Instituto Valenciano de Oncología (IVO) |
| Study Director: | Carles Pericay, Oncologist | Complejo Sanitario Parc Taulí |
| Principal Investigator: | Antonieta Salud, Oncologist | Hospital Arnau de Villanova (Lérida) |
| Principal Investigator: | Vicente Alonso, Oncologist | Hospital Miguel Servet |
| Principal Investigator: | María José Safont, Oncologist | Hospital General Universitario de Valencia |
| Principal Investigator: | Ruth Vera, Oncologist | Hospital de Navarra |
| Principal Investigator: | Pilar Escudero, Oncologist | Hospital Clínico Universitario Lozano Blesa |
| Principal Investigator: | Joan Maurel, Oncologist | Hospital Clinic i Provincial de Barcelona |
| Principal Investigator: | Jorge Aparicio, Oncologist | Hospital La Fe |
| Principal Investigator: | Jaime Feliú, Oncologist | Hospital La Paz |
| Principal Investigator: | Mengual, Radiotherapy | Instituto Valenciano de Oncología (IVO) |
| Principal Investigator: | Moisés Miraflores, Radiotherapy | Hospital Arnau de Vilanova (Lérida) |
| Principal Investigator: | Martín Tejedor Gutierrez, Radiotherapy | Hospital Miguel Servet |
| Principal Investigator: | Ana Hernández Machancoses, Radiotherapy | Hospital General Universitario de Valencia |
| Principal Investigator: | Fernando Arias de la Vega, Radiotherapy | Hospital de Navarra |
| Principal Investigator: | Javier Valencia, Radiotherapy | Hospital Clínico Universitario Lozano Blesa |
| Principal Investigator: | Carles Conill, Radiotherapy | Hospital Clinic i Provincial de Barcelona |
| Principal Investigator: | Alejandro Tormo Micó, Radiotherapy | Hospital La Fe |
| Principal Investigator: | María Elena Sánchez Santos, Radiotherapy | Hospital La Paz |
| Principal Investigator: | Jorge Campos, Surgeon | Instituto Valenciano de Oncología (IVO) |
| Principal Investigator: | Enrique Sierra Grañón, Surgeon | Hospital Arnau de Vilanova (Lérida) |
| Principal Investigator: | Andrés Monzón, Surgeon | Hospital Miguel Servet |
| Principal Investigator: | José Vicente Roig, Surgeon | Hospital General Universitario de Valencia |
| Principal Investigator: | Javier Suárez Alecha, Surgeon | Hospital de Navarra |
| Principal Investigator: | Eloy Tejero, Surgeon | Hospital Clínico Universitario Lozano Blesa |
| Principal Investigator: | Antonio Lazy, Surgeon | Hospital Clinic i Provincial de Barcelona |
| Study Director: | Rafael Estevan, Surgeon | Hospital La Fe |
| Principal Investigator: | Damián García Olmo, Surgeon | Hospital La Paz |
| Principal Investigator: | Jesús Santos, Radiologist | Instituto valenciano de Oncología (IVO) |
| Study Director: | Ana Darnell, Radiologist | Complejo Sanitario Parc Taulí |
| Principal Investigator: | Luís Sarriá, Radiologist | Hospital Miguel Servet |
| Principal Investigator: | Vicente Martínez Sanjuán, Radiologist | Hospital General Universitario de Valencia |
| Principal Investigator: | Javier Jiménez, Radiologist | Hospital de Navarra |
| Principal Investigator: | José Antonio Fernández Gómez, Radiologist | Hospital Clínico Universitario Lozano Blesa |
| Principal Investigator: | Juan Ramón Ayuso, Radiologist | Hospital Clinic i Provincial de Barcelona |
| Principal Investigator: | Fernando Mas Estellés, Radiologist | Hospital La Fe |
| Principal Investigator: | Paula Alegría Hidalgo, Radiologist | Hospital La Paz |
| Study Director: | Anna Caltrava, Pathologist | Instituto Valenciano de Oncología (IVO) |
| Principal Investigator: | Alex Casalots, Pathologist | Complejo Sanitario de Parc Taulí |
| Principal Investigator: | Xavier Matias-Guiu Guia, Pathologist | Hospital Arnau de Vilanova (Lérida) |
| Principal Investigator: | Carlos Hörndler, Pathologist | Hospital Miguel Servet |
| Principal Investigator: | Encarna Martínez, Pathologist | Hospital General Universitario de Valencia |
| Principal Investigator: | María Luisa Gómez Dorronsoro, Pathologist | Hospital de Navarra |
| Principal Investigator: | Javier Ortego, Pathologist | Hospital Clinico Universitario Lozano Blesa |
| Principal Investigator: | María José Artes, Pathologist | Hospital La Fe |
More Information
| Responsible Party: | GEMCAD ( Dr. Carlos Fernandez Martos ) |
| Study ID Numbers: | GEMCAD-0801 |
| Study First Received: | March 23, 2009 |
| Last Updated: | December 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00909987 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
rectum intermediate risk cancer rectum neoadjuvant |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents |
Growth Inhibitors Capecitabine Digestive System Neoplasms Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |