NCT00226473
Unknown
Phase 4
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Dermatologic Cooperative Oncology Group13 sites in 1 country200 target enrollmentSeptember 2001
ConditionsMetastatic Melanoma
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Metastatic Melanoma
- Sponsor
- Dermatologic Cooperative Oncology Group
- Enrollment
- 200
- Locations
- 13
- Primary Endpoint
- Overall survival
- Last Updated
- 19 years ago
Overview
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%.
Investigators
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)
Outcomes
Primary Outcomes
Overall survival
Secondary Outcomes
- Quality of life analysis
- Objective tumor response rate in study arm B
- Time to tumor progression
- Cost analysis
Study Sites (13)
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