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| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
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This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.
Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELOX/Avastin | Experimental | Capecitabine Oxaliplatin Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | 2 - 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile | Toxicity assessment on each cycle | |
| Time to tumor progression | 1 year | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Souglakos, MD | University Hospital of Crete, Dep of Medical Oncology | Principal Investigator |
| Lampros Vamvakas, MD | University Hospital of Crete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | Alexandroupoli | Greece | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24755296 | Derived | Vamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277. |
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|
| Capecitabine | Drug | Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles |
|
|
| Bevacizumab | Drug | Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles |
|
|
| 1 year |
| Air Forces Military Hospital of Athens |
| Athens |
| Greece |
| IASO General Hospital of Athens, 1st Dep of Medical Oncology | Athens | Greece |
| Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Athens | Greece |
| State General Hospital of Larissa | Larissa | Greece |
| Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Thessaloniki | Greece |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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