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Phase II Study of Neo Adjuvant Treatment With Avastin, Xeloda and/or Eloxatin in Colorectal Cancer (AXE BEAM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00828672
First received: January 23, 2009
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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).


Condition Intervention Phase
Advanced Colorectal Cancer Drug: Oxaliplatin Drug: Bevacizumab Drug: Capecitabine Radiation: radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Pathologic complete response (ypT0N0) rate [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Histopathologic R0 and negative CRM resection rate [ Time Frame: 4 months ]
  • Pathologic downstaging (yp T0-2 N0) rate [ Time Frame: 4 months ]
  • Tumor regression grade [ Time Frame: 3 months ]
  • Clinical response rate [ Time Frame: 3 months ]
  • Toxicity [ Time Frame: continuous up to 1 year ]
  • Loco-regional and distant recurrence rates [ Time Frame: up to 5 years ]
  • Progression-free and overall survival [ Time Frame: up to 5 years ]

Estimated Enrollment: 80
Actual Study Start Date: June 2009
Estimated Study Completion Date: March 2019
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
Drug: Oxaliplatin
Administered on days 15,22,29,36 en 43; 50 mg/m2
Other Name: Eloxatin
Drug: Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Other Name: Avastin
Drug: Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
Other Name: Xeloda
Radiation: radiotherapy
Total dose 45Gy
Active Comparator: AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
Drug: Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Other Name: Avastin
Drug: Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
Other Name: Xeloda
Radiation: radiotherapy
Total dose 45Gy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is at least 18 years of age
  • Good organ function
  • Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum

Exclusion Criteria:

  • Evidence of distant metastases
  • Contraindication for bevacizumab
  • Pregnant or breastfeeding women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828672

Locations
Belgium
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
ZNA Middelheim
Antwerp, Belgium, ZNA Middelheim
AZ St- Lucas
Brugge, Belgium, 8310
Erasme Hospital
Brussels, Belgium, 1070
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
AZ Groeninge
Kortrijk, Belgium, 8500
C.H.U. Sart-Tilman
Liege, Belgium, 4000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
H. Hartziekenhuis
Roeselare, Belgium, 8800
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Eric Van Cutsem, Prof. Dr. UZ Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00828672     History of Changes
Other Study ID Numbers: s51104 - ML5194
2007-007177-23 ( EudraCT Number )
MO19051 ( Other Grant/Funding Number: Roche )
Study First Received: January 23, 2009
Last Updated: May 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
assess activity
bevacizumab
capecitabine
radiation therapy
oxaliplatin
pre-operative treatment
TME (total mesorectal excision).

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Capecitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017