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| Name | Class |
|---|---|
| Groupe Francais De Pneumo-Cancerologie | OTHER |
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The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| Gemcitabine | Drug | |||
| Taxol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Complete response | ||
| 2-Partial response | ||
| 3-Stable disease | ||
| 4-Progression |
| Measure | Description | Time Frame |
|---|---|---|
| -Toxicity (NCI-CTC criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Vergnengre, MD | University Hospital, Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie | Beauvais | France | ||||
| Service de Pneumologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19155999 | Result | Vergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff. |
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| Bordeaux |
| France |
| Service de Pneumologie | Charleville Mezière | France |
| Service de Pneumologie | Créteil | France |
| Service de Pneumologie | Draguignan | France |
| Service de Pneumologie | Elbeuf | France |
| Service de Pneumologie | Gap | France |
| Service de Pathologie Respiratoire | Limoges | France |
| Service de Pneumologie, Hôpital de la Croix Rousse | Lyon | France |
| Service de Pneumologie | Mantes-la-Jolie | France |
| Département des Maladies Respiratoires | Marseille | France |
| Service de Pneumologie-Allergologie | Martigues | France |
| Service de Pneumologie | Meaux | France |
| Service de Pneumologie | Mulhouse | France |
| Service de Pneumologie - Hôpital St Antoine | Paris | France |
| Service de Pneumologie, Hôpital Pontchailloux | Rennes | France |
| Hôpital Charles Nicolle, Service de Pneumologie | Rouen | France |
| Service de Pneumologie, Hôpital Bois Guillaume | Rouen | France |
| Service de Pneumologie, Hôpital Nord | Saint-Etienne | France |
| Service de Pathologie Respiratoire | Toulon Naval | France |
| Service de Pneumologie | Villefranche | France |
| 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 |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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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