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Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy

NCT01434147 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-03-07

No results posted yet for this study

Summary

Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma

Conditions

Interventions

DRUG

preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine

Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Austrian Breast & Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Dietmar Öfner, MD, Head · Austrian Breast & Colorectal Cancer Study Group

  • Alexander de Vries, MD, Head · Austrian Breast & Colorectal Cancer Study Group

  • Wolfgang Eisterer, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Austria

Study Locations

More Related Trials

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 NCT01434147 on ClinicalTrials.gov