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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
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Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel +Carboplatin +concomitant chemoradiation | Experimental | Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks) |
|
| C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom | Experimental | Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing | From enrollment to first response assesment |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate at 1 year | 1 year | |
| Time to progression | Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12) | From enrollment to first progression date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Garrido, MD | Hospital Ramon y Cajal (Madrid) | Principal Investigator |
| Rafael Rosell, MD | Germans Trias i Pujol Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23611405 | Derived | Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, Cardenal F, Arnaiz Mdel M, Moran T, Morera R, Isla D, Valencia J, Cobo M, Delgado R, Garcia-Gomez R, Calvo F, Zamora J, Ramos A, Massuti B. Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer. 2013 Jul;81(1):84-90. doi: 10.1016/j.lungcan.2013.03.009. Epub 2013 Apr 21. |
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| Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d | Drug |
|
| Overall Survival | Arm B: 14.3 m and arm C: 14.7 m; p= 0.3 | From enrollment to last follow up or death |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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