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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Nº: 2008-001825-32 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
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The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOX: Docetaxel, oxaliplatin, Capecitabine | Drug |
Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment) |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | 2008-2011 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | 2008-2011 | |
| Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity | 2008-2011 |
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Inclusion Criteria:
Exclusion Criteria:
non measurable lesion as only disease evidence
previous chemotherapy treatment for advance disease. It wont´t be consider as exclusion criteria if chemo or radiotherapy has been given for localized disease and finished more than 1 year ago. In caso os only measurable disease in the radiated area, progressive disease has to be documented previous to the inclusion
functional dependency
hypersensitivity to Docetaxel, oxaliplatin or capecitabine
previous serious adverse events or unexpected to fluoropirimidin treatment and /or patients with proved deficit in dehidropirimidin deshidrogenase (DPD)
patients classified as "weak or fragile"
Cardiac concomitant present:
active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º, it is required thorax X:ray, hemoculture and urine culture 5 days previous to the inclusion)
severe or bad controlled concomitant disease
neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years
patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment
not able to fulfill the protocol and follow-up
being involve in any investigational trial with any drug within 4 weeks prior the study treatment
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Rivera, MD; phD | Hospital Marques de Valdecilla. Santander. Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish Cooperative Group for Gastrointestinal Tumour Therapy | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25491381 | Derived | Rivera F, Massuti B, Salcedo M, Sastre J, Martinez Galan J, Valladares-Ayerbes M, Serrano R, Garcia de Paredes ML, Manzano JL, Galan M, Alsina M, Yuste Izquierdo AL, Lopez C, Diaz-Rubio E, Conde V, Reboredo M, Cano MT, Pachon V, Aranda E. Phase II trial of miniDOX (reduced dose docetaxel-oxaliplatin-capecitabine) in "suboptimal" patients with advanced gastric cancer (AGC). TTD 08-02. Cancer Chemother Pharmacol. 2015 Feb;75(2):319-24. doi: 10.1007/s00280-014-2641-3. Epub 2014 Dec 10. |
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|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| 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 |
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