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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003995-36 | EudraCT Number |
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The purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.
The standard treatment for advanced small cell lung cancer (SCLC) is combination chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this combination have been based on calculating a patient's body surface area. This method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. Recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. This study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | standard fixed doses |
|
| B | Experimental | toxicity adjusted dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | 80 mg/m2 on day 1 for 6 cycles |
| |
| etoposide |
| Measure | Description | Time Frame |
|---|---|---|
| objective response | after 3 and 6 cycles of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | during and after each treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Gridelli, M.D. | S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology | Principal Investigator |
| Massimo Di Maio, M.D. | Giannettasio Hospital, Department of Oncology and Hematology | Principal Investigator |
| Francesco Perrone, M.D., Ph.D | National Cancer Institute Naples, Italy; Director Clinical Trials Unit | Principal Investigator |
| Ciro Gallo, M.D., Ph.D | Second University of Naples, Italy; Chair of Medical Statistics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria S. Giuseppe Moscati | Monteforte Irpino | AV | Italy | |||
| Azienda Ospedaliera G. Rummo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28625627 | Derived | Morabito A, Daniele G, Costanzo R, Favaretto AG, Filipazzi V, Rossi A, Gebbia V, Castiglione F, Cavanna L, Maiello E, Sandomenico C, Bonanno L, Piazza E, Maione P, Piccirillo MC, Di Maio M, Rocco G, Gallo C, Perrone F, Gridelli C. A multicenter, randomized, phase 3 trial comparing fixed dose versus toxicity-adjusted dose of cisplatin + etoposide in extensive small-cell lung cancer (SCLC) patients: The Small-cell-lung cancer Toxicity Adjusted Dosing (STAD-1) trial. Lung Cancer. 2017 Jun;108:15-21. doi: 10.1016/j.lungcan.2017.02.016. Epub 2017 Feb 27. |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Drug |
100 mg/m2 on days 1,2,3 for 6 cycles |
|
| cisplatin | Drug | cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle |
|
| etoposide | Drug | etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle |
|
| Benevento |
| BN |
| Italy |
| Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico | Palermo | PA | 90146 | Italy |
| Istituto Oncologico Veneto | Padova | PD | Italy |
| Ospedale E. Morelli | Sondalo | SO | 23039 | Italy |
| Ospedale San Lazzaro | Alba | Italy |
| Ospedale Mater Domini | Catanzaro | Italy |
| Ospedale L. Sacco Polo Universitario | Milan | Italy |
| Istituto Nazionale dei Tumori | Naples | Italy |
| Ospedale Cotugno | Naples | Italy |
| Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| Ospedale Maggiore | Trieste | Italy |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011034 |
| Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |