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Sponsored by: |
Austrian Society Of Surgical Oncology |
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Information provided by: | Austrian Society Of Surgical Oncology |
ClinicalTrials.gov Identifier: | NCT00444041 |
Major attempt is being given to the potential of curing patients with metastatic colorectal cancer due to the recognition of dramatic change in survival figures achieved in palliative chemotherapy combination treatment protocols. Achieving resectablity rates in previously unresectable patients has been defined as study endpoint among other well known primary and secondary objectives. Curing metastatic colorectal cancer is most likely in resectable patients and therefore the logical next step after completion of chemotherapy combination studies (e.g. EORTC 40983) is the addition of targeted agents. Bevacizumab has the most valid data of improving outcome figures and was therefore chosen as additional agent. Safety of the combination with Xelox was demonstrated in our pilot trial (Gruenberger JCO 2006, ASCO 2006, WCGC 2006, ESMO 2006), consequently response rate and resection rate will be the primary endpoints in this trial.
STUDY OBJECTIVES
Primary Objective The primary objective of this study is the Resectability (R0) rate after neoadjuvant Bevacizumab in potentially resectable mCRC.
Secondary Objectives The secondary objectives of this study include
STUDY DURATION Recruitment is planned for 12 months. Patients will be treated for 6 cycles XELOX and 5 cycles Bevacizumab. Surgery will be performed 2 weeks after the last Capecitabine administration, allowing a time window of 5 weeks between the last Bevacizumab administration and surgery.
Therapy with 6 cycles of XELOX and Bevacizumab will be restarted 4-5 weeks after surgery.
With a Follow up period of 2 years after the last enrolled patient, in order to assess RFS and OS, the trial will last for approx. 3 years.
NUMBER OF CENTRES Four centres with a high level of experience in the surgery of liver metastases are planned to participate in this study.
SELECTION CRITERIA
Total Number of Patients and Target Population The planned total sample size for this study is 43 patients. Patients with potentially resectable metastatic colorectal cancer previously untreated for metastatic disease will be enrolled in this trial.
Condition | Intervention | Phase |
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Metastatic Colorectal Cancer |
Drug: Bevacizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer (mCRC). A Multicenter, Single Arm Phase I/II Academic Trial |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Thomas Gruenberger, MD | +43 1 40400 ext 5621 | thomas.gruenberger@meduniwien.ac.at |
Austria | |
Medical University Hospital Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Thomas Gruenberger, MD +43 1 40400 ext 5621 thomas.gruenberger@meduniwien.ac.at | |
Contact: Michael Gnant, MD +43 1 40400 michael.gnant@meduniwien.ac.at | |
Principal Investigator: Thomas Gruenberger, MD |
Principal Investigator: | Thomas Gruenberger, MD | Austrian Society Of Surgical Oncology |
Study ID Numbers: | ACO-ASSO-LM1 |
Study First Received: | March 5, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00444041 |
Health Authority: | Austria: Agency for Health and Food Safety |
metastatic colorectal cancer surgery chemotherapy |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Bevacizumab Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |