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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000127-24 | EudraCT Number |
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The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental chemotherapy | Experimental | Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks. |
|
| Standard chemotherapy | Other | Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug |
| ||
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants alive one year after randomisation | Three and a half years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression or death due to any cause | Three and a half years | |
| Number of participants with grade 3 and 4 toxicities caused by treatments | Day 1 of every cycle and 30 days after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of cmet by immunohistochemistry | Analysis of archived tumour tissue (primary biopsy, previous surgical resection specimen if available) and metastatic tumour tissue for consenting subjects. | Three and a half years |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C Petersen, MD | Finsen Center, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Finsen Center, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34086514 | Derived | Petersen PC, Petersen LN, Vogelius I, Bjerregaard JK, Baeksgaard L. A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma. Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 Jun 4. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D015251 | Epirubicin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
| Capecitabine | Drug |
|
| Epirubicin | Drug |
|
| Oxaliplatin | Drug |
|
| Time until death due to any cause | Three and a half years |
| Changes in quality-of-life | Three and a half years |
| The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced | Five years |
| Registration of further lines of therapy | Five years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |