Know Cancer

or
forgot password

Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma, Adjuvant Therapy

Thank you

Trial Information

Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Description:

All registered deaths, not only melanoma-specific.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Johan Hansson, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Karolinska Institutet, Stockholm, Sweden

Authority:

Sweden: Medical Products Agency

Study ID:

Nordic-IFN-melanoma trial

NCT ID:

NCT01259934

Start Date:

November 1996

Completion Date:

June 2008

Related Keywords:

  • Melanoma
  • Adjuvant Therapy
  • Randomized Phase III trial
  • Adjuvant therapy
  • Interferon
  • Melanoma
  • Melanoma

Name

Location