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Xeloda and Bevacizumab to Treat Rectal Cancer

NCT00847119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-08-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ramon Salazar, Phd · Institut Català d'Oncologia

  • Margarita Garcia, MD · Institut Català d'Oncologia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-06-30
Completion
2015-02-28

Countries

  • Spain

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Drugs
Diseases
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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 NCT00847119 on ClinicalTrials.gov