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Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

NCT00828672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-07-10

Study results available
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Summary

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

Oxaliplatin

Administered on days 15,22,29,36 en 43; 50 mg/m2

DRUG

Bevacizumab

Administered on days 1,15,29 and 43 ; 5mg/kg

DRUG

Capecitabine

825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy

RADIATION

radiotherapy

Total dose 45Gy

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Eric Van Cutsem, Prof. Dr. · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-03-31
Completion
2019-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT00828672 on ClinicalTrials.gov