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Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.
The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy treatment | Experimental | Tailored chemotherapy by Therapeutic Targets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Chemotherapy | Drug | Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by: K-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Cubillo, Md PhD | Grupo Hospital madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Integral Oncológico Clara campal | Madrid | Madrid | 28050 | Spain |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |