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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000164-25 | EudraCT Number |
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The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Gemcitabine | Active Comparator | Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks |
|
| B: Gemcitabine + Cisplatin | Experimental | Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks |
|
| C: Pemetrexed | Active Comparator |
| |
| D: Pemetrexed + Cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug |
| ||
| Pemetrexed |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| worst grade toxicity per patient | according to Common Toxicity Criteria for Adverse Events v. 4.03 | evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks |
| progression free survival |
| Measure | Description | Time Frame |
|---|---|---|
| identification of patient and lesion specific prognostic factors | 2 years | |
| identification of patient and lesion specific factors predictive of chemotherapy efficacy | 2 years |
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 |
| 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 |
| Massimo Di Maio, M.D. | National Cancer Institute, Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Lazzaro | Alba | Italy | ||||
| Ospedali Riunit Umberto I-Lancisi-Salesi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30028656 | Derived | Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials. J Clin Oncol. 2018 Sep 1;36(25):2585-2592. doi: 10.1200/JCO.2017.76.8390. Epub 2018 Jul 20. |
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| Drug |
500 mg/m2 day 1 every 3 weeks |
|
| Cisplatin | Drug | 60 mg/m2 day 1 every 3 weeks |
|
| 6 months |
| changes in quality of life | baseline and up to 18 weeks |
| objective response | after 9 and 18 weeks of therapy |
| Ancona |
| Italy |
| Oncologia Universitaria degli Studi di Roma | Aprilia | Italy |
| Ospedale Cardinal Massaia | Asti | Italy |
| S. Giuseppe Moscati | Avellino | Italy |
| Ospedale Senatore Antonio Perrino | Brindisi | Italy |
| Univeristaria Policlinico Monserrato di Cagliari | Cagliari | Italy |
| Ospedale A. cardarelli | Campobasso | Italy |
| U.L.S.S. 15 Veneto | Camposampiero | Italy |
| Ospedale Ramazzini di Carpi | Carpi | Italy |
| Azienda Ospedaliera Garibalda Nesimadi Catania | Catania | Italy |
| Policlinico vittorio Emanuele | Catania | Italy |
| Ospedale della Madonna della Navicella | Chioggia | Italy |
| Ospedale Civile di Faenza | Faenza | Italy |
| Ospedale Fabrizio Spaziani | Frosinone | Italy |
| IRCCS AOU San Martino IST Genova | Genova | Italy |
| Ospedale Villa Scassi | Genova | Italy |
| Azienda Ospedaliera Vito Fazzi | Lecce | Italy |
| Ospedale Civile di Legnano | Legnano | Italy |
| Ospedale Umberto I | Lugo | Italy |
| IRCCS-Meldola | Meldola | Italy |
| Ospedale L. Sacco Polo Universitario | Milan | Italy |
| Ospedale S. Paolo | Milan | Italy |
| U.L.S.S. 13 | Mirano | Italy |
| H San Gerardo | Monza | Italy |
| A.O.U. Federico II | Naples | Italy |
| Istituto Nazionale dei Tumori | Naples | Italy |
| Ospedale Cardirelli | Naples | Italy |
| Seconda Università di Napoli | Naples | Italy |
| Istituto Sacro Cuore Don Calabria | Negrar | Italy |
| Istituto Oncologico Veneto | Padova | Italy |
| Ospedale Civile Umberto I | Pagani | Italy |
| Azienda Ospedaleira Ospedali Riuniti Villa Sofia Cervello | Palermo | Italy |
| Casa di cura La Maddalena | Palermo | Italy |
| Fondazione Salvatore Maugeri | Pavia | Italy |
| A.O. San Carlo | Potenza | Italy |
| Irccs - Crob | Rionero in Vulture | Italy |
| AO San Camillo Forlanini | Roma | Italy |
| Campus Biomedico | Roma | Italy |
| Ospedale S. Giovanni Calibita Fatebenfratelli | Roma | Italy |
| Ospedale Guglielmo da Saliceto-USL di Piacenza | Saliceto | Italy |
| Oncologia IRCCS - Casa Sollievo Sofferenza | San Giovanni Rotondo | Italy |
| A.O. di Busto Arsizio | Saronno | Italy |
| Ospedale di Sondrio | Sondrio | Italy |
| Ospedale SS. Trinità | Sora | Italy |
| Ospedale S. Andrea | Vercelli | Italy |
| Ospedale S. Bortolo | Vicenza | Italy |
| ASL Viterbo Ospedale Belcolle | Viterbo | Italy |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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