Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006249
Status:
UNKNOWN
Last Update Posted:
2015-02-10
First Post:
2000-09-11
Brief Title:
Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III TxN1-2MO Melanoma Patients a Randomized Phase III Trial
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1200 patients 600 per treatment arm will be accrued for this study within 15-2 years
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 1200 patients 600 per treatment arm will be accrued for this study within 15-2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-18991 | None | None | None |