NCT00221702

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

7.3 years

First QC Date

September 13, 2005

Last Update Submit

October 12, 2010

Conditions

MelanomaNeoplasm Metastasis

Keywords

MelanomaNeoplasm metastasisInterferon alfa-2bAdjuvantsRandomized clinical trialDisease-free survival timeSafetyDrug toxicityQuality of life

Outcome Measures

Primary Outcomes (1)

  • disease-free survival time

    5-year

Secondary Outcomes (4)

  • time to distant metastasis

    the time from the inclusion to the first documentation of any distant metastasis

  • overall survival

    the time from the inclusion to the date of death regardless of the specific cause

  • toxicity

    for 36 months

  • quality of life

    36 months

Study Arms (2)

A

EXPERIMENTAL

Peg Intron 100 mcg SC/week for 36 months

Drug: PegIntron

B

ACTIVE COMPARATOR

Intron A 3 X 3 MIU, weekly, sc, for 18 months

Drug: intron A

Interventions

PegIntronDRUG

100 mcg SC/week for 36 months

A
intron ADRUG

3mui TIWW SC for 18 months

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any prior chemo-, immuno-, hormonal or radiation therapy
  • Macroscopic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHM, dermatology

Marseille, 13274, France

Location

Related Publications (1)

  • Grob JJ, Jouary T, Dreno B, Asselineau J, Gutzmer R, Hauschild A, Leccia MT, Landthaler M, Garbe C, Sassolas B, Herbst RA, Guillot B, Chene G, Pehamberger H. Adjuvant therapy with pegylated interferon alfa-2b (36 months) versus low-dose interferon alfa-2b (18 months) in melanoma patients without macrometastatic nodes: an open-label, randomised, phase 3 European Association for Dermato-Oncology (EADO) study. Eur J Cancer. 2013 Jan;49(1):166-74. doi: 10.1016/j.ejca.2012.07.018. Epub 2012 Sep 10.

    PMID: 22975216DERIVED

MeSH Terms

Conditions

MelanomaNeoplasm MetastasisDrug-Related Side Effects and Adverse Reactions

Interventions

peginterferon alfa-2bIntrons

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Jean - Jacques GROB, Professor

    University Hospital, Marseille

    PRINCIPAL INVESTIGATOR

  • Geneviève Chêne, Professor

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

FR(1)