Clinical trial NCT00226473: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Official title: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Melanoma
Keywords: malignant Melanoma
Chemotherapy
Metastasis
standard palliative care
best supportive care
Lead sponsor: Dermatologic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Quality of life analysis
measure: Objective tumor response rate in study arm B
measure: Time to tumor progression
measure: Cost analysis
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim
state: Baden-Württemberg
city: Tuebingen
country: Germany
facility: Dept. of Dermatology, University Hospital Tuebingen
state: Baden-Württemberg
city: Frankfurt
country: Germany
facility: Dept. of Dermatology, University of Frankfurt
state: Hessen
city: Buxtehude
country: Germany
facility: Dept. of Dermatology, Medical Center Buxtehude
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Dept. of Dermatology, Hildesheim
state: Niedersachsen
city: Homburg
country: Germany
facility: Dept. of. Dermatology, University of Saarland, Homburg
state: Saaland
city: Magdeburg
country: Germany
facility: Dept. of Dermatology, University Otto von Guericke
state: Saxony-Anhalt
city: Kiel
country: Germany
facility: Dept. of Dermatology, University of Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Dept. of Dermatology, Helios Clinic Erfurt
state: Thuringia
city: Jena
country: Germany
facility: Dept. of Dermatology, University of Jena
state: Thuringia
city: Berlin
country: Germany
facility: Dept. of Dermatology, Charité Berlin
city: Berlin
country: Germany
facility: Dept. of Dermatology, Vivantes Clinics
Study officials:
affiliation: Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany
name: Jens Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany
name: Axel Hauschild, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany
name: Peter Mohr, MD
role: STUDY_DIRECTOR
References:
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