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| Name | Class |
|---|---|
| Hospital Universitario de Fuenlabrada | OTHER |
| Grupo Hospital de Madrid | OTHER |
| Apices Soluciones S.L. | INDUSTRY |
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The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples.
It is a prospective, randomized study in patients with metastatic colorectal carcinoma progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive chemotherapy as determined by its oncologist or treatment according to chemosensitivity profile obtained. For obtaining the profile a histological tumor sample and a sample of venous blood in a tube with heparin standard are necessary . This latter sample will be processed to isolate circulating tumor cells by cell adhesion with matrix coated glass spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor biopsies from the same patients will be extracted by a standard procedure for extracting RNA for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated a ranked list of potentially more effective treatments in every case
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Control treatment and will be treated with any of the schemes used in the study according to the discretion of the physician. |
|
| Arm B | Experimental | Treatment guided by the gene expression profiles obtained from the CTC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A chemotherapy | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference | 12 months |
| gene expression profiles | Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
chronic active liver disease of any origin, and / or cirrhosis with Child-Pugh score B or C.
Uncontrolled active infection. carries the human immunodeficiency virus (HIV). Any other significant disease that in the opinion of the investigator, substantially increase the risk associated with patient participation in this study.
documented symptomatic brain metastases, progression or requiring corticosteroids or associated to a leptomeningeal involvement.
Patients with uncontrolled systemic diseases. Patients with Hypertension or Diabetes Mellitus is countable if at the time of inclusion deemed medically controlled.
Patients with inability for oral drug delivery, either by preventing gastrointestinal administration situation or severe impairment of intestinal absorption
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Gómez, M.D.,Ph.D | Centro Nacional de Investigaciones Oncológicas (CNIO) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28950 | Spain | ||
| Hospital Madrid Norte Sanchinarro |
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| arm B chemotherapy | Drug |
|
|
| Madrid |
| Madrid |
| 28050 |
| Spain |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| D000068818 | Cetuximab |
| D004317 | Doxorubicin |
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| D019772 | Topotecan |
| D016685 | Mitomycin |
| D000077150 | Oxaliplatin |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| C068874 | raltitrexed |
| D000077157 | Sorafenib |
| D000069347 | Erlotinib Hydrochloride |
| D000077235 | Vinorelbine |
| D000069439 | Dasatinib |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D056831 | Coordination Complexes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D011799 | Quinazolines |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
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