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Nordic Adjuvant IFN Melanoma Trial

NCT01259934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 855

Last updated 2010-12-14

No results posted yet for this study

Summary

The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

Conditions

Interventions

DRUG

Interferon-alpha2b - 1 year

Induction: IFN-alpha2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alpha2b, 10 MU (flat dose), 3 days/week, SC, 12 months

DRUG

Interferon-alpha2b - 2 years

Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months

Sponsors & Collaborators

Principal Investigators

  • Johan Hansson, MD,PhD · Karolinska Institutet

  • Steinar Aamdal, MD. PhD · Oslo University Hospital, Oslo, Norway

  • Lars Bastholt, MD,PhD · Odense University Hospital

  • Micaela Hernberg, MD, PhD · Helsinki University Central Hospital, Helsinki, Finland

  • Ulrika Stierner, MD PhD · Sahlgrenska University Hospital

  • Hans von der Maase, MD PhD · Copenhagen University Hospital, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-11-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

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 NCT01259934 on ClinicalTrials.gov