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The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Every 3 weeks intravenous cisplatin plus etoposide |
|
| B | Experimental | Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin + etoposide | Drug | Cisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival will be dated from the day of randomisation until death or last follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Every 3 cycles of chemotherapy | |
| Toxicity | After every cycle of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Sculier, MD, PhD | European Lung Cancer Working Party | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Brussels | 1000 | Belgium | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28975084 | Derived | Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017. |
| Label | URL |
|---|---|
| Click here for more information on the protocol | View source |
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| Epirubicin + ifosfamide + etoposide | Drug | Epirubicin 60 mg/m² day 1, every 3 weeks Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks |
|
| Department of Pneumology CHRU Lille |
| Lille |
| France |
| Hellenic Cancer Institute - St Savas Oncology Hospital | Athens | Greece |
| Medical Oncology Hospital de Sagunto | Valencia | Spain |
| Trials registry of the French National Cancer Institute | View source |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C075609 | PE regimen |
| D015251 | Epirubicin |
| D007069 | Ifosfamide |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| 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 |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
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