Status:
COMPLETED
PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Schering-Plough
Conditions:
Melanoma
Neoplasm Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Melanoma with a tumor thickness \>= 1.5mm without clinically detectable nodes represents an increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of IFN alpha can p...
Detailed Description
Study design and primary objective This is an European multicenter, open label, prospective randomized phase III trial evaluating the efficacy of long-term maintenance therapy of two therapy options,...
Eligibility Criteria
Inclusion
- Histologically proven cutaneous melanoma
- Tumour thickness \>= 1.5 mm (Breslow staging)
- Absence of clinically detectable regional node metastasis, no evidence of distant metastasis
- Informed consent form signed
Exclusion
- Any prior chemo-, immuno-, hormonal or radiation therapy
- Macroscopic disease
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
898 Patients enrolled
Trial Details
Trial ID
NCT00221702
Start Date
June 1 2003
End Date
October 1 2010
Last Update
October 13 2010
Active Locations (1)
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1
APHM, dermatology
Marseille, France, 13274