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| ID | Type | Description | Link |
|---|---|---|---|
| INRC-PITCAP | |||
| EU-20202 | |||
| INRC-ITA | |||
| NCI-V01-1665 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| chemotherapy | Drug | |||
| cisplatin | Drug | |||
| paclitaxel | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| One-year survival rate and mean survival time | ||
| Objective response rate and local control | ||
| Tolerability |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
Measurable disease
No involvement of supraclavicular lymph nodes
No cytologically positive pleural or pericardial effusion
No invasion to the wall of the esophagus or the cardiac ventricle
No bone marrow involvement
No distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bruzzi, MD, MPH, PhD | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile di Asti | Asti | 14100 | Italy | |||
| Centro di Riferimento Oncologico - Aviano |
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| Safety profile, in terms of acute and delayed toxicity |
| Aviano |
| 33081 |
| Italy |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| Spedali Civili di Brescia | Brescia | 25133 | Italy |
| Civic Hospital of Carrara | Carrara | I-54033 | Italy |
| Ospedale Regionale A. Pugliese | Catanzaro | 88100 | Italy |
| Ospedale Mariano Santo | Cosenza | 87100 | Italy |
| Azienda Istituti Ospitalieri | Cremona | 26100 | Italy |
| Ospedale Santa Croce | Cuneo | 12100 | Italy |
| Ospedale Galliera Oncologia | Genoa | 16100 | Italy |
| Istituto Nazionale per la Ricerca sul Cancro | Genoa | 16132 | Italy |
| Ospedale San Martino | Genoa | 16132 | Italy |
| Ospedale Civile di Ivrea | Ivrea | 10015 | Italy |
| Ospedale Santa Maria Goretti | Latina | 04100 | Italy |
| Ospedale Umberto I | Lugo DI Romagna | 48022 | Italy |
| Istituto Policlinico San Donato | Milan | 20097 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | Milan | 20133 | Italy |
| University of Modena Hospital and Reggio Emilia School of Medicine | Modena | 41100 | Italy |
| Nuovo Ospedale San Gerardo at University of Milano-Bicocca | Monza | 20052 | Italy |
| Azienda Ospedale S. Luigi at University of Torino | Orbassano | 10043 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Azienda Ospedaliera Di Parma | Parma | 43100 | Italy |
| Policlinico Monteluce | Perugia | 06122 | Italy |
| Ospedale Santa Chiara Pisa | Pisa | 56100 | Italy |
| Ospedale Sta. Maria Delle Croci | Ravenna | 48100 | Italy |
| Ospedale Carlo Forlanini | Rome | 00149 | Italy |
| Ospedale S. Camillo-Forlanini | Rome | 00152 | Italy |
| Azienda Policlinico Umberto Primo | Rome | 00161 | Italy |
| Istituti Fisioterapici Ospitalieri - Roma | Rome | 00161 | Italy |
| Istituto Regina Elena | Rome | 00161 | Italy |
| Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| Azienda Ospedaliera S. Maria | Terni | 051100 | Italy |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Turin | 10123 | Italy |
| Ospedale Evangelico Valdese | Turin | 10125 | Italy |
| Ospedale Ostetrico Ginecologica Sant Anna | Turin | 10125 | Italy |
| Azienda Ospedaliera Santa Maria della Misericordia | Udine | 33100 | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D004358 | Drug Therapy |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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