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PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)

NCT00221702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 898

Last updated 2010-10-13

No results posted yet for this study

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 provide a benefit in this group. However, the impact of low dose IFN alpha is not sustained after the treatment period. A longer treatment may prolong the benefit and thus have a more clear-cut impact on disease-free and overall survival. The tolerance and the impact on quality of life are limiting factors in a group of patients whose individual course is not necessarily poor. PegIntron may be better tolerated than instant release interferon, and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus treatment schedule with PegIntron is not expected to increase the cost of standard care significantly.

Conditions

Interventions

DRUG

PegIntron

100 mcg SC/week for 36 months

DRUG

intron A

3mui TIWW SC for 18 months

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean - Jacques GROB, Professor · University Hospital, Marseille

  • Geneviève Chêne, Professor · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221702 on ClinicalTrials.gov