Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

Phase 3

• Conditions: Melanoma (Skin)

• Registration Number: NCT00006249
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.

Detailed Description

OBJECTIVES:

* Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation, in terms of distant metastases-free survival, in patients with previously resected stage III melanoma.

* Compare the overall survival in these patients after treatment with pegylated interferon alfa vs observation.

* Determine the toxicity of pegylated interferon alfa in these patients.

* Determine the compliance of these patients treated with pegylated interferon alfa.

* Compare the quality of life in these patients after treatment with pegylated interferon alfa vs observation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor (absent vs present vs unknown), sex, and center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years.

* Arm II: Patients undergo observation only. Treatment continues in the absence of distant metastases or unacceptable toxicity.

Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 1.5-2 years.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1258

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
distant-metastasis free-survival (DMFS)	from randomization	distant-metastasis free-survival (DMFS) after randomization

Secondary Outcome Measures

Name	Time	Method
toxicity	from randomization	toxicity
survival	from randomization till death	duration of survival: time from randomization until death, whatever the cause

Trial Locations

Locations (103)

Peter MacCallum Cancer Institute; 🇦🇺 East Melbourne, Victoria, Australia

Austin and Repatriation Medical Centre; 🇦🇺 Heidelberg West, Victoria, Australia

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

Sir Charles Gairdner Hospital, Perth; 🇦🇺 Perth, Western Australia, Australia

David Maddison Clincial Sciences; 🇦🇺 Newcastle, Australia

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Clinique Notre Dame de Grace; 🇧🇪 Gosselies, Belgium

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