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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

APHM, dermatology

Marseille, France, 13274