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The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin, Vindesine, Dacarbazine (drugs) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life analysis | ||
| Objective tumor response rate in study arm B | ||
| Time to tumor progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Ulrich, MD | Contact | +49-391-6715428 | jens.ulrich@medizin.uni-magdeburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Jens Ulrich, MD | Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany | Principal Investigator |
| Axel Hauschild, MD | Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim | Recruiting | Mannheim | Baden-Wurttemberg | D-68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10561349 | Background | Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745. | |
| 10561229 |
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| Cost analysis |
| Peter Mohr, MD | Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany | Study Director |
| Dept. of Dermatology, University Hospital Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | D-72076 | Germany |
|
| Dept. of Dermatology, University of Frankfurt | Recruiting | Frankfurt am Main | Hesse | D-60590 | Germany |
|
| Dept. of Dermatology, Medical Center Buxtehude | Recruiting | Buxtehude | Lower Saxony | D-21641 | Germany |
|
| Dept. of Dermatology, Hildesheim | Recruiting | Hildesheim | Lower Saxony | D-31134 | Germany |
|
| Dept. of. Dermatology, University of Saarland, Homburg | Recruiting | Homburg | Saaland | D-66421 | Germany |
|
| Dept. of Dermatology, University Otto von Guericke | Recruiting | Magdeburg | Saxony-Anhalt | D-39120 | Germany |
|
| Dept. of Dermatology, University of Schleswig-Holstein | Recruiting | Kiel | Schleswig-Holstein | D-24105 | Germany |
|
| Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck | Recruiting | Lübeck | Schleswig-Holstein | D-23538 | Germany |
|
| Dept. of Dermatology, Charité Berlin | Recruiting | Berlin | State of Berlin | D-10098 | Germany |
|
| Dept. of Dermatology, Vivantes Clinics | Recruiting | Berlin | State of Berlin | D-12351 | Germany |
|
| Dept. of Dermatology, Helios Clinic Erfurt | Recruiting | Erfurt | Thuringia | 99012 | Germany |
|
| Dept. of Dermatology, University of Jena | Recruiting | Jena | Thuringia | D-07740 | Germany |
|
| Creagan ET, Suman VJ, Dalton RJ, Pitot HC, Long HJ, Veeder MH, Vukov AM, Rowland KM, Krook JE, Michalak JC. Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma. J Clin Oncol. 1999 Jun;17(6):1884-90. doi: 10.1200/JCO.1999.17.6.1884. |
| 10661773 | Background | Cure H, Souteyrand P, Ouabdesselam R, Roche H, Ravaud A, D'incan M, Viens P, Fargeot P, Lentz MA, Fumoleau P, Hanauske A, Chollet P. Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group. Melanoma Res. 1999 Dec;9(6):607-10. doi: 10.1097/00008390-199912000-00011. |
| 9093725 | Background | Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668. |
| 11308250 | Background | Hauschild A, Garbe C, Stolz W, Ellwanger U, Seiter S, Dummer R, Ugurel S, Sebastian G, Nashan D, Linse R, Achtelik W, Mohr P, Kaufmann R, Fey M, Ulrich J, Tilgen W. Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: a randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). Br J Cancer. 2001 Apr 20;84(8):1036-42. doi: 10.1054/bjoc.2001.1731. |
| 10839290 | Background | Propper DJ, Levitt NC, O'Byrne K, Braybrooke JP, Talbot DC, Ganesan TS, Thompson CH, Rajagopalan B, Littlewood TJ, Dixon RM, Harris AL. Phase II study of the oxygen saturation curve left shifting agent BW12C in combination with the hypoxia activated drug mitomycin C in advanced colorectal cancer. Br J Cancer. 2000 Jun;82(11):1776-82. doi: 10.1054/bjoc.2000.1138. |
| 10403690 | Background | Thongprasert S, Sanguanmitra P, Juthapan W, Clinch J. Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy. Lung Cancer. 1999 Apr;24(1):17-24. doi: 10.1016/s0169-5002(99)00017-3. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D014751 | Vindesine |
| D003606 | Dacarbazine |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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