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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

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.

Condition or disease Intervention/treatment Phase
Melanoma Neoplasm Metastasis Drug: PegIntron Drug: intron A Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 898 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2003
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: A
Peg Intron 100 mcg SC/week for 36 months
Drug: PegIntron
100 mcg SC/week for 36 months

Active Comparator: B
Intron A 3 X 3 MIU, weekly, sc, for 18 months
Drug: intron A
3mui TIWW SC for 18 months

Primary Outcome Measures :
  1. disease-free survival time [ Time Frame: 5-year ]

Secondary Outcome Measures :
  1. time to distant metastasis [ Time Frame: the time from the inclusion to the first documentation of any distant metastasis ]
  2. overall survival [ Time Frame: the time from the inclusion to the date of death regardless of the specific cause ]
  3. toxicity [ Time Frame: for 36 months ]
  4. quality of life [ Time Frame: 36 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221702

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APHM, dermatology
Marseille, France, 13274
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Jean - Jacques GROB, Professor University Hospital, Marseille
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jean Pierre LEROY/ Clinical Research and innovation Director, University Hospital Bordeaux Identifier: NCT00221702    
Other Study ID Numbers: 9267-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010
Keywords provided by University Hospital, Bordeaux:
Neoplasm metastasis
Interferon alfa-2b
Randomized clinical trial
Disease-free survival time
Drug toxicity
Quality of life
Additional relevant MeSH terms:
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Nevi and Melanomas
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents