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| ID | Type | Description | Link |
|---|---|---|---|
| CSET 2011/1827 | Other Identifier | Institut Gustave Roussy |
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The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with metastatic CRC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of treatment based on objective response rate | Every 9 weeks from the start to tumoral progression |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicity based on NCI-CTC v4.0 | Every 3 weeks from the start to tumoral progression or toxicity preventing further processing | |
| Progression Free Survival | Every 9 weeks form the start to tumoral progression |
| Measure | Description | Time Frame |
|---|---|---|
| Total area under the curve of contrast-enhanced liver ultrasound | Assessed up in baseline, D7, D14, W4, W7 and every 9 weeks up to progression |
Inclusion Criteria:
Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)
Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab
Age >18 years <75 years
Performance status WHO 0 or 1
Life expectancy >3 months
Bilirubin <1.5 times the upper limit of normal (N), ASAT and ALAT <5N, creatinine <1.5 N neutrophils >1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin >9g/dL. Patients may be included even if they were transfused
CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle
Information of the patient or legal representative signing the informed consent
Affiliated to a social security system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Ducreux, MD-PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | Val de Marne | 94805 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Capecitabine | Drug | Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4 |
|
| Irinotecan | Drug | Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line) |
|
| Hepatic metastasis resection rate | Assessed up 6 months after the end of treatment |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |