Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002763
Status:
UNKNOWN
Last Update Posted:
2011-11-16
First Post:
1999-11-01
Brief Title:
High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B INTRON-A TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA ANDOR REGIONAL LYMPHNODE METASTASES INTERMEDIATE-HIGH DOSE VS INTERMEDIATE-LOW DOSE IFN-ALFA VS OBSERVATION A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL
Status:
UNKNOWN
Status Verified Date:
2011-11
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 cancer cells It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma
Detailed Description:
OBJECTIVES I Evaluate the time to distant metastasis death due to melanoma and overall survival in patients with high-risk stage III melanoma treated with 10 MU of interferon alfa IFN-A for 4 weeks followed by 1 year of IFN-A at 10 MU three times per week vs 2 years of IFN-A at 5 MU three times per week vs observation alone II Assess the toxicity associated with IFN-A III Compare the quality of life costs and compliance associated with each treatment regimen
OUTLINE Randomized study Following definitive surgical resection patients are randomly assigned in a 221 ratio to Arms A B and C respectively Arm A Biological Response Modifier Therapy Interferon alfa-2b Schering IFN-A NSC-377523 Higher dose Arm B Biological Response Modifier Therapy IFN-A Lower dose Arm C Control Observation
PROJECTED ACCRUAL A total of 1000 patients will be entered over approximately 4 years in this multicenter study
OUTLINE Randomized study Following definitive surgical resection patients are randomly assigned in a 221 ratio to Arms A B and C respectively Arm A Biological Response Modifier Therapy Interferon alfa-2b Schering IFN-A NSC-377523 Higher dose Arm B Biological Response Modifier Therapy IFN-A Lower dose Arm C Control Observation
PROJECTED ACCRUAL A total of 1000 patients will be entered over approximately 4 years in this multicenter study
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-18952 | None | None | None |