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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002647-18 | EudraCT Number |
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At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUCiL | Experimental | Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence | After 3 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Control rate after the 2nd sequence | After 3 cycles | |
| Response rate after the 1st sequence | After 3 cycles | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaafar BENNOUNA, MD | Centre René Gauducheau - Nantes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avignon - Institut Sainte-Catherine | Avignon | 84918 | France | |||
| Caen - Centre François Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16421419 | Background | Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106. | |
| 22341744 |
| Label | URL |
|---|---|
| IFCT website | View source |
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| Bevacizumab | Drug | 7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence |
|
| Pemetrexed | Drug | 500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence. |
|
| 12 months |
| Quality of life | During Sequence 2 : at the beginning and after 3 cycles |
| Caen |
| 14000 |
| France |
| Caen - CHU Côte de Nacre | Caen | 14000 | France |
| Centre Hospitalier | Chauny | France |
| CH du Mans | Le Mans | France |
| Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques | Marseille | France |
| Mulhouse - CH | Mulhouse | 68000 | France |
| Nantes - Centre René Gauducheau | Nantes | 44805 | France |
| Hopital Tenon - Pneumologie | Paris | 75020 | France |
| HCL - Lyon Sud (Pneumologie) | Pierre-Bénite | 69495 | France |
| Rennes - CHU | Rennes | 35033 | France |
| Strasbourg - NHC | Strasbourg | 63000 | France |
| Background |
| Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16. |
| 19786657 | Background | Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28. |
| 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 |
| D000068258 | Bevacizumab |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
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