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Trial record 77 of 525 for:    melanoma phase III

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221702
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 13, 2010
Information provided by:
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE June 2003
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2007)
disease-free survival time [ Time Frame: 5-year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
- 5-year disease-free survival time
Change History Complete list of historical versions of study NCT00221702 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
  • time to distant metastasis [ Time Frame: the time from the inclusion to the first documentation of any distant metastasis ]
  • overall survival [ Time Frame: the time from the inclusion to the date of death regardless of the specific cause ]
  • toxicity [ Time Frame: for 36 months ]
  • quality of life [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • - time to distant metastasis
  • - overall survival
  • - toxicity
  • - quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)
Official Title  ICMJE Randomized, Multicenter Phase III Trial Comparing Adjuvant Treatment With PegIntron Over 36 Months Versus Reference Treatment With IntronA Over 18 Months in Cutaneous Melanoma Patients AJCC Stage II (>=1.5 mm Clinically Node Negative)
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.
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, IntronA for 18 months versus PegIntron for 36 months, administered in an adjuvant setting after the local excision of an intermediate risk cutaneous melanoma.

Eligibility criteria

Intermediate risk melanoma is defined by the following criteria: (1) a tumor thickness >= 1,5mm and (2) the absence of regional nodal macrometastases, as assessed either by clinical examination or, if sentinel lymph node biopsy (SLNB) or elective node dissection (ELND) are performed, by the absence of macroscopic evidence of disease. Patients with evidence of nodal micrometastasis by SLNB or ELND are eligible. The choice of performing sentinel node dissection will be left to the decision of each center, on condition to concern all consecutive patients and that all surgical procedures are completed before randomization of the patients . The centers have to inform their respective national study center if they perform SLNB or ELND and also if they change their surgical procedure.

Study treatments

  • Arm A : PegIntron 100 mcg SC/week for 36 months
  • Arm B : IntronA 3miu TIWW SC for 18 months


The primary endpoint of the study will be the time to any recurrence (local recurrence, satellite or in transit metastasis, regional node metastasis or distant metastasis) or death, whatever the cause. The primary comparison between the two arms will use the 5-year disease-free survival time. Secondary endpoints are time to distant metastasis , overall survival, toxicity and quality of life.

Therapy with either PegIntron or IntronA will continue as scheduled unless there is evidence of disease progression (whether local or distant recurrence), severe toxicity, or the subject requests that therapy be discontinued. All patients will be followed for disease-free-survival and overall survival until the end of the trial.

Sample size and analysis

The calculated sample size is 1190 patients to be enrolled over a 5 years period; this sample size is inclusive of an expected lost to follow up not more than 10% during the course of the trial. The randomization procedure will be stratified according to centers and to sentinel node biopsy. The primary analysis will be performed under the intent to treat principle.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: PegIntron
    100 mcg SC/week for 36 months
  • Drug: intron A
    3mui TIWW SC for 18 months
Study Arms  ICMJE
  • Experimental: A
    Peg Intron 100 mcg SC/week for 36 months
    Intervention: Drug: PegIntron
  • Active Comparator: B
    Intron A 3 X 3 MIU, weekly, sc, for 18 months
    Intervention: Drug: intron A
Publications * Grob JJ, Jouary T, Dréno 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2009)
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • Any prior chemo-, immuno-, hormonal or radiation therapy
  • Macroscopic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00221702
Other Study ID Numbers  ICMJE 9267-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean Pierre LEROY/ Clinical Research and innovation Director, University Hospital Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Schering-Plough
Investigators  ICMJE
Principal Investigator: Jean - Jacques GROB, Professor University Hospital, Marseille
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP