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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000846-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab as first line treatment of patients with metastatic colorectal cancer not previously treated and with three or more circulating tumoral cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | modified FOLFOX6 + bevacizumab |
|
| Experimental | Experimental | FOLFOXIRI+bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified FOLFOX6 + bevacizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 5 years | |
| Response rate (RR) | 5 years | |
| Radical Resection (R0) surgery rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo DÃaz-Rubio, MD-PhD | Hospital San Carlos, Madrid | Study Chair |
| Enrique Aranda, MD-PhD | Hospital Reina SofÃa | Study Chair |
| Javier Sastre, MD-PhD | Hospital San Carlos, Madrid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish Cooperative Group for Digestive Tumour Therapy | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40259317 | Derived | Valladares-Ayerbes M, Toledano-Fonseca M, Grana B, Jimenez-Fonseca P, Pulido-Cortijo G, Gil S, Sastre J, Salud A, Rivera F, Salgado M, Garcia-Alfonso P, Lopez Lopez R, Guillen-Ponce C, Rodriguez-Ariza A, Vieitez JM, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). Associations of blood RNA biomarkers and circulating tumour cells in patients with previously untreated metastatic colorectal cancer. BMC Cancer. 2025 Apr 21;25(1):743. doi: 10.1186/s12885-025-14098-9. | |
| 36944559 |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| FOLFOXIRI + Bevacizumab | Drug |
|
|
| 5 years |
| Circulating Tumour Cells (CTC) count basal and correlate to PFS, OS, RR | 5 years |
| Correlation of RAS, BRAF and PI3K mutations and clinical anti-tumour activity outcome ( PFS, OS, RR) | 5 years |
| Adverse events | 5 years |
| Correlation of molecular status of bio markers related to the cellular and tumoral reproduction and/or mode of action and clinical anti-tumour activity outcome ( PFS, OS, RR) | 5 years |
| Derived |
| Jimenez-Fonseca P, Sastre J, Garcia-Alfonso P, Gomez-Espana MA, Salud A, Gil S, Rivera F, Reina JJ, Quintero G, Valladares-Ayerbes M, Safont MJ, La Casta A, Robles-Diaz L, Garcia-Paredes B, Lopez Lopez R, Guillot M, Gallego J, Alonso-Orduna V, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNU-1 and Phase II VISNU-2 Randomized Trials. Clin Colorectal Cancer. 2023 Jun;22(2):222-230. doi: 10.1016/j.clcc.2023.02.004. Epub 2023 Feb 21. |
| 32278676 | Derived | Sastre J, Orden V, Martinez A, Bando I, Balbin M, Bellosillo B, Palanca S, Peligros Gomez MI, Mediero B, Llovet P, Moral VM, Vieitez JM, Garcia-Alfonso P, Calle SG, Ortiz-Morales MJ, Salud A, Quintero G, Lopez C, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Association Between Baseline Circulating Tumor Cells, Molecular Tumor Profiling, and Clinical Characteristics in a Large Cohort of Chemo-naive Metastatic Colorectal Cancer Patients Prospectively Collected. Clin Colorectal Cancer. 2020 Sep;19(3):e110-e116. doi: 10.1016/j.clcc.2020.02.014. Epub 2020 Mar 6. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| 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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