Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNR-NICO-01 | |||
| EU-97010 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.
OBJECTIVES:
OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA).
Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician.
PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| etoposide | Drug | |||
| adjuvant therapy | Procedure |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antonio Nicolucci, MD | Consorzio Mario Negri Sud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Papanicolaou General Hospital | Thessaloniki | 57010 | Greece | |||
| Ospedale Bassini |
Not provided
Not provided
Not provided
Not provided
Not provided
| Balsamo Cinisello |
| 20092 |
| Italy |
| Universita Degli Studi di Bari Policlinico | Bari | 70124 | Italy |
| Spedali Civili | Brescia | 25124 | Italy |
| Ospedale Oncologico A. Businco | Cagliari | 09121 | Italy |
| Cattedra di Oncologia Medica - Universita degli Studi di Cagliari | Cagliari | 09124 | Italy |
| Ospedale San Michele | Cagliari | 09134 | Italy |
| Ospedale Sant Anna | Como | 22100 | Italy |
| Ospedale Valduce | Como | 22100 | Italy |
| Ospedale Di Conselice | Conselice | 48017 | Italy |
| Ospedale Civile Cosenza | Cosenza | 87100 | Italy |
| Ospedale Maggiore Crema | Crema | 26013 | Italy |
| Ospedale Santa Croce | Cuneo | 12100 | Italy |
| Ospedale Civile Feltre | Feltre | 32100 | Italy |
| Universita di Ferrara | Ferrara | 44100 | Italy |
| Universita Degli Studi di Firenze - Policlin. di Careggi | Firenze (Florence) | 1 (50134) | Italy |
| Policlinico di Careggi | Firenze (Florence) | 50134 | Italy |
| U.S.L. 10 Villa Ognissanti | Florence | 50139 | Italy |
| Istituto Nazionale per la Ricerca sul Cancro | Genoa (Genova) | 16132 | Italy |
| Ospedale San Martino/Cliniche Universitarie Convenzionate | Genoa (Genova) | 16132 | Italy |
| Ospedale Galliera Oncologia | Genova (Genoa) | 16128 | Italy |
| Ospedale Di Gorgonzola | Gorgonzola | 20064 | Italy |
| Ospedale Alessandro Manzoni | Lecco | 23900 | Italy |
| Ospedale Legnago USSL 21 | Legnago | 37045 | Italy |
| Ospedale Maggiore Lodi | Lodi | I-20075 | Italy |
| Ospedale Umberto I | Lugo DI Romagna | 48022 | Italy |
| U.S.S.L. 72 Magenta | Magenta | 20013 | Italy |
| Carlo Poma Hospital | Mantua | 46100 | Italy |
| Ospedale Di Predabissi Melegnano | Melegnano | 20077 | Italy |
| Azienda USSL NO 8 | Merate | 22055 | Italy |
| Instituto Di Oncologia | Messina | 98122 | Italy |
| Ospedale Civile Umberto I | Mestre | 30174 | Italy |
| Ospedale San Giuseppe | Milan | 20100 | Italy |
| Consorzio Provinciale Antitubercolare | Milan | 20124 | Italy |
| Istituto Scientifico H.San Raffaele | Milan | 20132 | Italy |
| Istituto Di Science Biomediche San Paolo | Milan | 20142 | Italy |
| Casa Di Cura San Ambrogio | Milan | 20149 | Italy |
| Ospedale San Carlo Borromeo | Milano (Milan) | 20153 | Italy |
| Ospedale Luigi Sacco | Milano (Milan) | 20157 | Italy |
| Ospedale Maggiore Ca'Granda | Milano (Milan) | 20162 | Italy |
| Ospedale Santa Croce | Moncalieri | 10024 | Italy |
| Nuovo Ospedale San Gerardo | Monza | 20052 | Italy |
| Ospedale Civile Asilo Vittoria | Mortara | 27036 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | Naples | 80131 | Italy |
| Ospedale Vincenzo Monaldi | Naples | 80131 | Italy |
| Ospedale C. Ascalesi | Naples | 80139 | Italy |
| Federico II University Medical School | Naples (Napoli) | 80131 | Italy |
| Istituto Tumori/Fondazione Pascale | Naples (Napoli) | 80131 | Italy |
| Ospedale Civile Negrar | Negrar | 37024 | Italy |
| Azienda Ospedaliera di Padova | Padova (Padua) | 35128 | Italy |
| University of Padua | Padua | 35128 | Italy |
| Ospedale Civico E Benefratelli | Palermo | 90127 | Italy |
| Ospedale Maggiore Parma | Parma | 43100 | Italy |
| Ospedale Torrette University Ancona | Parma | 43100 | Italy |
| Ospedale Silvestrini | Perugia | 06132 | Italy |
| Ospedale Agnelli | Pinerolo | 10064 | Italy |
| Ospedale Sta. Maria Delle Croci | Ravenna | 48100 | Italy |
| Azienda Ospedaliera | Reggio Emilia | 42100 | Italy |
| Ospedale Civile Rho | Rho | 20017 | Italy |
| Istituti Fisioterapici Ospitalieri - Roma | Rome | 00128 | Italy |
| Ospedale San Filippo Neri | Rome | 00135 | Italy |
| Ospedale Carlo Forlanini | Rome | 00149 | Italy |
| Ospedale S. Camillo-Forlanini | Rome | 00152 | Italy |
| Azienda Policlinico Umberto Primo | Rome | 00161 | Italy |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| Policlinico Militare Celio | Rome | 00184 | Italy |
| ASL NO. 1 Imperiese | Sanremo | 18038 | Italy |
| Consorzio Mario Negri Sud | Santa Maria Imbaro | 66030 | Italy |
| Azienda USSL No 4 | Saronno | 21047 | Italy |
| Istituto Clinica Medica | Sassari | 07100 | Italy |
| Ospedale Sesto San Giovanni | Sesto San Giovanni | 20099 | Italy |
| Azienda Ospedaliera S. Maria | Terni | 05100 | Italy |
| Ospedale Generale Prov. Boldrini | Thiene | 36016 | Italy |
| Dispensario Igiene Sociale | Toino | 10100 | Italy |
| Clinica Universita | Torino | 10126 | Italy |
| Universita di Torino | Torino | 10126 | Italy |
| Ospedale S. Chiara | Trento | 38100 | Italy |
| Ospedale San Isidoro | Trescore Balneario | 24069 | Italy |
| Ospedale General Regional Ca Foncello | Treviso | 31100 | Italy |
| Ospedale Maggiore dell' Universita | Trieste | 34100 | Italy |
| Ospedale Cattinara | Trieste | Italy |
| Cattedra di Immunologia Clinica | Turin (TO) | 10128 | Italy |
| Universita Degli Studi di Udine | Udine | 33100 | Italy |
| Casa di Cura S. Maria | Varese | 21100 | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Inha University Hospital | Incheon | South Korea |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided