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Clinical Trials/NCT00226473
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

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%.

Registry
clinicaltrials.gov
Start Date
September 2001
End Date
September 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dermatologic Cooperative Oncology Group

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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