Adjuvant Therapy, Melanoma
Conditions
Keywords
Randomized Phase III trial, Adjuvant therapy, Interferon, Melanoma
Brief summary
The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.
Detailed description
This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (\> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases. The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.
Interventions
DRUGInterferon-alpha2b - 1 year
Induction: IFN-alpha2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alpha2b, 10 MU (flat dose), 3 days/week, SC, 12 months
DRUGInterferon-alpha2b - 2 years
Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months
Sponsors
Merck Sharp & Dohme LLC
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* T4 N0 M0 - Thick primary melanoma: \> 4.0 mm Breslow depth, without lymph node involvement, or * Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or * Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy. * ECOG performance status of 0-1 * No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol * Written informed consent
Exclusion criteria
* Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma * Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease * Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy * Female patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months | All registered deaths, not only melanoma-specific. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse free survival | Evaluated at regular intervals | Time from randomization to date of first reported melanoma recurrence or death |
| Safety-toxicity | Regular evaluations | All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria |
| Health related quality of life | Regular evaluations | Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up |
Countries
Sweden
Outcome results
None listed