Adjuvant PEG Intron in Ulcerated Melanoma
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|ClinicalTrials.gov Identifier: NCT01502696|
Recruitment Status : Active, not recruiting
First Posted : January 2, 2012
Last Update Posted : March 4, 2019
Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.
The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerated Melanomas||Biological: PEG IFN alfa-2b||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
|Experimental: PEG IFN alfa-2b||
Biological: PEG IFN alfa-2b
3µg/kg weekly injections
|No Intervention: Observation|
- Relapse-free survival (RFS) [ Time Frame: 6.3 years from first patient in ]
- Occurence of Adverse Events [ Time Frame: 6.3 years from first patient in ]This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
- Overall survival (OS) [ Time Frame: 7.8 years from first patient in ]
- Distant metastases-free survival (DMFS) [ Time Frame: 7.8 years from first patient in ]
- Quality of life [ Time Frame: 6 years from from first patient in ]
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 ClinicalTrials.gov identifier (NCT number): NCT01502696
|Study Chair:||Alexander Eggermont, MD, PHD||Institut Gustave Roussy, Paris, France|