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Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

NCT01043484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-10-19

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Conditions

Interventions

DRUG

Bevacizumab + Capecitabine + Radiotherapy

Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

DRUG

Capecitabine + Radiotherapy

Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Ramón Salazar · Institut Català d´Oncologia (ICO) L'Hospitalet. Barcelona. Spain

  • Cristina Grávalos · Hospital 12 Octubre. Madrid. Spain

  • Sebastiano Biondo · Hospital Universitario de Bellvitge.Barcelona. Spain

  • Amalia Palacios · Hospital Universitario Reina Sofía. Córdoba. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-01-31
Completion
2016-08-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043484 on ClinicalTrials.gov