Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

Phase 4

• Conditions: Metastatic Melanoma

• Registration Number: NCT00226473
• Lead Sponsor: Dermatologic Cooperative Oncology Group

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-25
• Study First Submitted QC: 2005-09-25
• Study First Posted: 2005-09-27
• Last Update Submitted: 2006-06-20
• Last Update Posted: 2006-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• histological diagnosis of metastatic melanoma (stage IV)
• progressive disease after first-line chemotherapy or immuno-chemotherapy
• Karnofsky-index > 60%
• informed consent

Exclusion Criteria

• Uvea melanoma
• another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
• severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Quality of life analysis
Objective tumor response rate in study arm B
Time to tumor progression
Cost analysis

Trial Locations

Locations (13)

Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Dept. of Dermatology, University of Jena; 🇩🇪 Jena, Thuringia, Germany

Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Dept. of Dermatology, University of Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Dept. of Dermatology, Medical Center Buxtehude; 🇩🇪 Buxtehude, Niedersachsen, Germany

Dept. of Dermatology, Hildesheim; 🇩🇪 Hildesheim, Niedersachsen, Germany

Dept. of Dermatology, Vivantes Clinics; 🇩🇪 Berlin, Germany

Dept. of Dermatology, Charité Berlin; 🇩🇪 Berlin, Germany

Dept. of Dermatology, University of Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Dept. of Dermatology, University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany

Dept. of Dermatology, Helios Clinic Erfurt; 🇩🇪 Erfurt, Thuringia, Germany

Dept. of Dermatology, University Otto von Guericke; 🇩🇪 Magdeburg, Saxony-Anhalt, Germany

Dept. of. Dermatology, University of Saarland, Homburg; 🇩🇪 Homburg, Saaland, Germany