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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
| EORTC Lung Cancer Cooperative Group | OTHER |
| Spanish Lung Cancer Group | OTHER |
| Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK) |
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This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease. | |
| 2 | Experimental | Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEC2 Vaccine | Biological | 5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 6 monthly basis until progression of disease |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 6 monthly basis until progression of disease | |
| Safety | 6 monthly basis until progression of disease | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8433390 | Background | Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. | |
| 8220363 |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| UNKNOWN |
| US Department of Veterans Affairs | FED |
| Groupe Francais De Pneumo-Cancerologie | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Independent centers (Australia, New Zealand, Europe, USA) | UNKNOWN |
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| 6 monthly basis until progression of disease |
| Health Economics Aspects | 6 monthly basis until progression of disease |
| Sprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life. Qual Life Res. 1993 Aug;2(4):287-95. doi: 10.1007/BF00434800. |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |