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

Melanoma Clinical Trial

— EADO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221702
• Other study ID #: 9267-01
• Secondary ID: 2001-034
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 12, 2010
• Start date: June 2003
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Neoplasm Metastasis

Intervention

Drug:
• PegIntron
100 mcg SC/week for 36 months
• intron A
3mui TIWW SC for 18 months

Locations

Country	Name	City	State
France	APHM, dermatology	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Schering-Plough

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival time		5-year	No
Secondary	time to distant metastasis		the time from the inclusion to the first documentation of any distant metastasis	No
Secondary	overall survival		the time from the inclusion to the date of death regardless of the specific cause	No
Secondary	toxicity		for 36 months	Yes
Secondary	quality of life		36 months	No