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| ID | Type | Description | Link |
|---|---|---|---|
| ITA-INTN-DISTAL | |||
| EU-20103 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | ||
| Toxicity | ||
| Response rate | ||
| Time to progression | ||
| Survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Gridelli, MD | Istituto Nazionale per lo Studio e la Cura dei Tumori | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Di Ricovero E Cura A Carattere Scientifico | Bari | 70126 | Italy | |||
| Azienda Ospedaliena G. Rummo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17416857 | Background | Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251. | |
| 15558071 |
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| 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 |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Benevento |
| 82100 |
| Italy |
| Ospedale Cardarelli - Campobasso | Campobasso | Italy |
| Ospedale Civile Cosenza | Cosenza | 87100 | Italy |
| Ospedale San Giuseppe | Milan | 20153 | Italy |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Ospedale San Paolo | Milan | 20142 | Italy |
| Federico II University Medical School | Naples | 80131 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | Naples | 80131 | Italy |
| Ospedale Vincenzo Monaldi | Naples | 80131 | Italy |
| Seconda Universita di Napoli | Naples | 80133 | Italy |
| Ospedale Civile P.F. Calvi | Noale | Italy |
| Azienda Ospedaliera Policlinico Paolo Giaccone | Palermo | 90127 | Italy |
| Ospedale La Maddalena - Palermo | Palermo | Italy |
| Ospedale San Carlo | Potenza | 85100 | Italy |
| Ospedale da Procida | Salerno | Italy |
| Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |