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

NCT ID: NCT00221702

Last Updated: 2010-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 898 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-10-31

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

Endpoints

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.

Conditions

Melanoma; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Peg Intron 100 mcg SC/week for 36 months

Group Type: EXPERIMENTAL

PegIntron

Intervention Type: DRUG

100 mcg SC/week for 36 months

B

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

Group Type: ACTIVE_COMPARATOR

intron A

Intervention Type: DRUG

3mui TIWW SC for 18 months

Interventions

PegIntron

100 mcg SC/week for 36 months

Intervention Type: DRUG

intron A

3mui TIWW SC for 18 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Bordeaux

Principal Investigators

Jean - Jacques GROB, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Marseille

Geneviève Chêne, Professor

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

APHM, dermatology

Marseille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 22975216 (View on PubMed)

Other Identifiers

2001-034

Identifier Type: -

Identifier Source: secondary_id

9267-01

Identifier Type: -

Identifier Source: org_study_id