Ulcerated MelanomasPhase 3NCT01502696
Adjuvant PEG Intron in Ulcerated Melanoma
A Phase 3 study testing PEG IFN alfa-2b in people with Ulcerated Melanomas, run by European Organisation for Research and Treatment of Cancer - EORTC at 58 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerated Melanomas
- What is being tested?
- PEG IFN alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 58 sitesin 12 countries
- Study dates
- Oct 2012to Apr 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between 18-70 years old.
- Subjects must have histologically documented ulcerated primary cutaneous melanomas with T(2-4)b N0M0.
- Adequate resection of ulcerated primary cutaneous melanoma. 1 to 2 cm normal tissue excision margins according to Breslow thickness are recommended. In the head and neck areas and in case of locations distally on extremities, narrower margins are acceptable as long as they are radical (see Appendix F). Subjects must have recovered from the effects of recent surgery.
- SNB must occur within 12 weeks prior randomization.
- Subjects must have an ECOG performance status of 0 or 1 (See Appendix B).
- Subjects must have adequate bone marrow, renal and hepatic function as defined by the following parameters obtained up to maximum 12 weeks prior to randomization:
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- Hematology:
- WBC >= 3.0 x 109/L
- Neutrophils > 1.5 x 109/L
- Platelets > 100 x 109/L
- Hemoglobin >= 9 g/dL or 5.6 mmol/L
- Adequate Renal and Hepatic function:
- Serum creatinine < 2.0 mg/dL or < 140 µmol/L
- SGOT and SGPT < 2 times upper normal limit of laboratory normal (ULN)
Who cannot join
- No mucosal melanoma nor ocular melanoma.
- No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB). Sentinel Node staging after the excision of the primary must be done between the date of final excision of the primary and the date of randomization.
- No evidence of regional nor distant lymph node metastases nor satellites/in-transit metastases (even if they have been resected).
- No evidence of distant metastasis on clinical examination, CT/MRI of full chest, abdomen and pelvis. Neck CT/MRI if head and neck primary.
- No clinical evidence of brain metastasis.
- No pregnant women
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- No breast feeding women
- No patients with a medical condition requiring chronic systemic corticosteroids are not eligible.
- No experimental therapy within 30 days prior to randomization in this study.
- No prior chemotherapy, immunotherapy/vaccine, hormonal or radiation therapy for melanoma.
- No prior treatment with interferon-alfa for any reason.
- No history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- No severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) nor symptomatic ischemic heart disease.
- No thyroid dysfunction not responsive to therapy.
- No poorly controlled (HBA1C>8%) diabetes mellitus or uncontrolled diabetes mellitus, i.e. elevated fasting serum glucose should be < 110% ULN).
- No active autoimmune disease.
- No active and/or uncontrolled infection, including active hepatitis.
- No history of seropositivity for HIV.
- No history of neuropsychiatric disorder requiring hospitalization.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
58 sites in 12 countries.
58 sites in 12 countries
France14 sites
Assistance Publique - Hopitaux de Paris - Hopital Avicenne
Bobigny
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France
Bordeaux
CHU de Grenoble - La Tronche - Hôpital A. Michallon
Grenoble
CHRU de Lille
Lille
Centre Leon Berard
Lyon
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone
Marseille
CHU de Nice - CHU de Nice - Hopital De L'Archet
Nice
Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare
Paris
Assitance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard
Paris
Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis
Paris
Institut Gustave Roussy
Paris
Centre Hospitalier De Pau
Pau
CHU de Reims - Hôpital Robert Debré
Reims
CHU d'Amiens - CHU Amiens - Hopital Sud
Salouël
United Kingdom13 sites
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust
Bebington
University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elisabeth Medical Centre
Birmingham
Mid Essex Hospitals - Broomfield Hospital
Broomfield
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge
Cheltenham General Hospital
Cheltenham
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds
St George's Hospital NHS Trust (6961)
London
The Christie NHS Foundation Trust
Manchester
Norfolk And Norwich Hospital
Norwich
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton
St Helens and Knowsley Teaching Hospitals
St Helens
Germany9 sites
Universitaetsklinikum Koeln
Cologne
Universitaetsklinikum
Essen
Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department
Heidelberg
Universitaetsklinikum Heidelberg - Hautklinik
Heidelberg
Universitaetsklinikum Schleswig-Holstein
Kiel
Medizinische Universitaet Zu Luebeck
Lübeck
Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center
Mainz
UniversitaetsMedizin Mannheim
Mannheim
Universitaetsklinikum Wuerzburg
Würzburg
Italy5 sites
IRCCS - Istituto Tumori "Giovanni Paolo II"
Bari
Istituto Europeo di Oncologia
Milan
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
Istituto Dermopatico Dell'Immacolata
Roma
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine
Udine
Belgium3 sites
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels
Universitair Ziekenhuis Gent
Ghent
U.Z. Leuven - Campus Gasthuisberg
Leuven
Denmark3 sites
Aarhus University Hospital
Aarhus, 8000
Herlev Hospital - University Copenhagen
Herlev
Odense University Hospital
Odense
Netherlands3 sites
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam
Vrije Universiteit Medisch Centrum
Amsterdam
Leiden University Medical Centre
Leiden
Portugal3 sites
I.P.O. Francisco Gentil - Centro De Lisboa
Lisbon, 1099-023
I.P.O. Francisco Gentil - Centro De Lisboa
Lisbon
Hospital Distrital De Santarem
Santarém
Spain2 sites
Hospital Clinic Universitari
Barcelona
Hospital Universitario 12 De Octubre
Madrid
About this study
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.
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.
- Conditions
- Ulcerated Melanomas
- Being tested
- PEG IFN alfa-2b
- Keywords
- ulcerated primary cutaneous melanoma, Stage II, PEG IFN alfa-2b, T(2-4)bN0M0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG IFN alfa-2bBiological
3µg/kg weekly injections
| Study group | Role | What they receive |
|---|---|---|
| PEG IFN alfa-2b | Experimental | Not described Receives: Biological: PEG IFN alfa-2b |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
Measured: 6.3 years from first patient in
Secondary outcomes (4)
Occurence of Adverse Events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Measured: 6.3 years from first patient in
Overall survival (OS)
Measured: 7.8 years from first patient in
Distant metastases-free survival (DMFS)
Measured: 7.8 years from first patient in
Quality of life
Measured: 6 years from from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerated MelanomasStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- NCIC Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Alexander Eggermont, MD, PHD, Study chair, Institut Gustave Roussy, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502696
- Sponsor's protocol ID
- EORTC-18081
- Other IDs
- 2009-010273-20, 2009
- Status last verified
- Feb 2019
- First submitted
- 22 Dec 2011
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01502696
- Acronym / sponsor ID
- EORTC-18081
- Conditions
- Ulcerated Melanomas
- Keywords
- ulcerated primary cutaneous melanoma, Stage II, PEG IFN alfa-2b, T(2-4)bN0M0
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- NCIC Clinical Trials Group
- Study start
- Oct 2012
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG IFN alfa-2b | Experimental | Biological: PEG IFN alfa-2b |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must be between 18-70 years old.
- Subjects must have histologically documented ulcerated primary cutaneous melanomas with T(2-4)b N0M0.
- Adequate resection of ulcerated primary cutaneous melanoma. 1 to 2 cm normal tissue excision margins according to Breslow thickness are recommended. In the head and neck areas and in case of locations distally on extremities, narrower margins are acceptable as long as they are radical (see Appendix F). Subjects must have recovered from the effects of recent surgery.
- SNB must occur within 12 weeks prior randomization.
- Subjects must have an ECOG performance status of 0 or 1 (See Appendix B).
Key exclusion criteria (20 listed)
- No mucosal melanoma nor ocular melanoma.
- No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB). Sentinel Node staging after the excision of the primary must be done between the date of final excision of the primary and the date of randomization.
- No evidence of regional nor distant lymph node metastases nor satellites/in-transit metastases (even if they have been resected).
- No evidence of distant metastasis on clinical examination, CT/MRI of full chest, abdomen and pelvis. Neck CT/MRI if head and neck primary.
- No clinical evidence of brain metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG IFN alfa-2b3µg/kg weekly injections | Biological | PEG IFN alfa-2b |
Primary outcome
Relapse-free survival (RFS)
Time frame: 6.3 years from first patient in
4 secondary outcomes
Occurence of Adverse Events
Time frame: 6.3 years from first patient in
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Eggermont, MD, PHD study chair
Institut Gustave Roussy, Paris, France
58 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG IFN alfa-2b in people with Ulcerated Melanomas, run by European Organisation for Research and Treatment of Cancer - EORTC at 58 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France, United Kingdom, Germany, Italy, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: 6.3 years from first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.