Phase II Study of Neo Adjuvant Treatment With Avastin, Xeloda and/or Eloxatin in Colorectal Cancer (AXE BEAM)
This study is currently recruiting participants.
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00828672
First received: January 23, 2009
Last updated: January 8, 2013
Last verified: January 2013
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Histopathologic R0 and negative CRM resection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Pathologic downstaging (yp T0-2 N0) rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Tumor regression grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Clinical response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: continuous up to 1 year ] [ Designated as safety issue: Yes ]
- Loco-regional and distant recurrence rates [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Progression-free and overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (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
Other Name: Radiotherapy
|
|
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
Other Name: Radiotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828672
Contacts
| Contact: Eric Van Cutsem, Prof. Dr | 016/344.418 | eric.vancutsem@uz.kuleuven.ac.be |
| Contact: Karin Haustermans, Prof.Dr | karin.haustermans@uz.kuleuven.ac.be |
Locations
| Belgium | |
| Onze Lieve Vrouwziekenhuis | Recruiting |
| Aalst, Belgium, 9300 | |
| Contact: Luc Verbeke, Dr Luc.Verbeke@olvz-aalst.be | |
| Principal Investigator: Luc Verbeke, Dr | |
| ZNA Middelheim | Recruiting |
| Antwerp, Belgium, ZNA Middelheim | |
| Contact: Sabine Vanderkam, Dr sabine.vanderkam@zna.be | |
| Principal Investigator: Sabine Vanderkam, Dr | |
| AZ St- Lucas | Recruiting |
| Brugge, Belgium, 8310 | |
| Contact: Joris Arts, MD joris.arts@stlucas.be | |
| Principal Investigator: Joris Arts, Dr | |
| AZ Sint-Jan | Withdrawn |
| Brugge, Belgium, 8000 | |
| Cliniques Universitaires St Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Yves Humblet, Prof.Dr Yves.Humblet@uclouvain.be | |
| Principal Investigator: Yves Humblet, Prof.Dr | |
| Erasme Hospital | Recruiting |
| Brussels, Belgium, 1070 | |
| Contact: Jean-Luc Van Laethem, Prof.MD JL.VanLaethem@erasme.ulb.ac.be | |
| Principal Investigator: Jean-Luc Van Laethem, Prof.Dr. | |
| Salvator Ziekenhuis | Not yet recruiting |
| Hasselt, Belgium, 3500 | |
| Contact: Daan Walgraeve, Dr daan.walgraeve@caz.be | |
| Principal Investigator: Daan Walgraeve, Dr | |
| AZ Groeninge | Recruiting |
| Kortrijk, Belgium, 8500 | |
| Contact: Philippe Vergauwe, Dr philippe.vergauwe@azgroeninge.be | |
| Principal Investigator: Philippe Vergauwe, Dr | |
| C.H.U. Sart-Tilman | Recruiting |
| Liege, Belgium, 4000 | |
| Contact: Marc Polus, Dr marc.polus@chu.ulg.ac.be | |
| Principal Investigator: Marc Polus, Dr | |
| Clinique Sainte Elisabeth | Recruiting |
| Namur, Belgium, 5000 | |
| Contact: Jean-Francois Daisne, Dr jfdaisne@gmail.com | |
| Principal Investigator: Jean-Francois Daisne, Dr | |
| H. Hartziekenhuis | Recruiting |
| Roeselare, Belgium, 8800 | |
| Contact: Jochen Decaestecker, Dr jdecaestecker@hhr.be | |
| Principal Investigator: Jochen Decaestecker, Dr | |
| Algemeen Ziekenhuis Sint-Augustinus | Withdrawn |
| Wilrijk, Belgium, 2610 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
| Principal Investigator: | Eric Van Cutsem, Prof. Dr. | UZ Leuven |
More Information
No publications provided
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT00828672 History of Changes |
| Other Study ID Numbers: | s51104 - ML5194, 2007 - 007177 - 23, MO19051 |
| Study First Received: | January 23, 2009 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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 Oxaliplatin Capecitabine Bevacizumab |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013