Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Summary

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.

Conditions

• Rectum Cancer

Interventions

DRUG

Capecitabine

PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)

DRUG

Oxaliplatin

IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)

DRUG

Bevacizumab

IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)

RADIATION

Radiotherapy

Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).

DRUG

Capecitabine during all Radiotherapy period

825 mg/m2 bid

PROCEDURE

Total Mesorectal Excision (TME)

4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• Grupo Espanol Multidisciplinario del Cancer Digestivo

  lead OTHER

Principal Investigators

• Carlos Fernández Martos, Oncologist · Instituto Valenciano de Oncología (IVO)

• Carles Pericay, Oncologist · Complejo Sanitario Parc Taulí

• Antonieta Salud, Oncologist · Hospital Arnau de Villanova (Lérida)

• Vicente Alonso, Oncologist · Hospital Miguel Servet

• María José Safont, Oncologist · Hospital General Universitario de Valencia

• Ruth Vera, Oncologist · Hospital de Navarra

• Pilar Escudero, Oncologist · Hospital Clínico Universitario Lozano Blesa

• Joan Maurel, Oncologist · Hospital Clinic i provincial de Barcelona

• Jorge Aparicio, Oncologist · Hospital La Fe

• Jaime Feliú, Oncologist · Hospital La Paz

• Mengual, Radiotherapy · Instituto Valenciano de Oncología (IVO)

• Moisés Miraflores, Radiotherapy · Hospital Arnau de Vilanova (Lérida)

• Martín Tejedor Gutierrez, Radiotherapy · Hospital Miguel Servet

• Ana Hernández Machancoses, Radiotherapy · Hospital General Universitario de Valencia

• Fernando Arias de la Vega, Radiotherapy · Hospital de Navarra

• Javier Valencia, Radiotherapy · Hospital Clínico Universitario Lozano Blesa

• Carles Conill, Radiotherapy · Hospital Clinic i provincial de Barcelona

• Alejandro Tormo Micó, Radiotherapy · Hospital La Fe

• María Elena Sánchez Santos, Radiotherapy · Hospital La Paz

• Jorge Campos, Surgeon · Instituto Valenciano de Oncología (IVO)

• Enrique Sierra Grañón, Surgeon · Hospital Arnau de Vilanova (Lérida)

• Andrés Monzón, Surgeon · Hospital Miguel Servet

• José Vicente Roig, Surgeon · Hospital General Universitario de Valencia

• Javier Suárez Alecha, Surgeon · Hospital de Navarra

• Eloy Tejero, Surgeon · Hospital Clínico Universitario Lozano Blesa

• Antonio Lazy, Surgeon · Hospital Clinic i provincial de Barcelona

• Rafael Estevan, Surgeon · Hospital La Fe

• Damián García Olmo, Surgeon · Hospital La Paz

• Jesús Santos, Radiologist · Instituto valenciano de Oncología (IVO)

• Ana Darnell, Radiologist · Complejo Sanitario Parc Taulí

• Luís Sarriá, Radiologist · Hospital Miguel Servet

• Vicente Martínez Sanjuán, Radiologist · Hospital General Universitario de Valencia

• Javier Jiménez, Radiologist · Hospital de Navarra

• José Antonio Fernández Gómez, Radiologist · Hospital Clínico Universitario Lozano Blesa

• Juan Ramón Ayuso, Radiologist · Hospital Clinic i provincial de Barcelona

• Fernando Mas Estellés, Radiologist · Hospital La Fe

• Paula Alegría Hidalgo, Radiologist · Hospital La Paz

• Anna Caltrava, Pathologist · Instituto Valenciano de Oncología (IVO)

• Alex Casalots, Pathologist · Complejo Sanitario de Parc Taulí

• Xavier Matias-Guiu Guia, Pathologist · Hospital Arnau de Vilanova (Lérida)

• Carlos Hörndler, Pathologist · Hospital Miguel Servet

• Encarna Martínez, Pathologist · Hospital General Universitario de Valencia

• María Luisa Gómez Dorronsoro, Pathologist · Hospital de Navarra

• Javier Ortego, Pathologist · Hospital Clinico Universitario Lozano Blesa

• María José Artes, Pathologist · Hospital La Fe

• Marta Martín Richard, Oncologist · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Manuel Gallén, Oncologist · Hospital del Mar

• Javier Gallego, Oncologist · Hospital General Universitario de Elche

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2013-01-31

Completion

2013-06-30

Countries

• Spain

Study Locations