Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072124
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-11-04
Brief Title:
Dacarbazine andor Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
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 Drugs used in chemotherapy such as dacarbazine and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Complete metastasectomy may be an effective treatment for metastatic melanoma and may improve quality of life and help patients live longer and more comfortably It is not yet known whether complete metastasectomy is more effective than chemotherapy in treating stage IV melanoma
PURPOSE This randomized phase III trial is studying dacarbazine andor cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma
PURPOSE This randomized phase III trial is studying dacarbazine andor cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine andor cisplatin
Secondary
Compare time to progression in patients treated with these regimens
Determine the response rate in patients treated with dacarbazine andor cisplatin
Compare the morbidity and quality of life of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior exposure to dacarbazine and cisplatin yes vs no and number of sites of metastases 1 vs 2 or more Patients are randomized to 1 of 2 treatment arms
Arm I surgery Patients undergo complete metastasectomy Patients with disease progression after surgery may undergo repeat resection or may receive dacarbazine andor cisplatin as in arm II
Arm II systemic therapy Patients receive dacarbazine IV over 30-60 minutes andor cisplatin IV over 30 minutes on days 1 2 3 22 23 and 24 1 course Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 1 additional course of chemotherapy beyond CR and are eligible for other investigational strategies
Quality of life is assessed at baseline at 3 and 6 months and at 1 year
Patients are followed every 3-4 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 74 patients 37 per treatment arm will be accrued for this study within 4 years
Primary
Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine andor cisplatin
Secondary
Compare time to progression in patients treated with these regimens
Determine the response rate in patients treated with dacarbazine andor cisplatin
Compare the morbidity and quality of life of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior exposure to dacarbazine and cisplatin yes vs no and number of sites of metastases 1 vs 2 or more Patients are randomized to 1 of 2 treatment arms
Arm I surgery Patients undergo complete metastasectomy Patients with disease progression after surgery may undergo repeat resection or may receive dacarbazine andor cisplatin as in arm II
Arm II systemic therapy Patients receive dacarbazine IV over 30-60 minutes andor cisplatin IV over 30 minutes on days 1 2 3 22 23 and 24 1 course Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 1 additional course of chemotherapy beyond CR and are eligible for other investigational strategies
Quality of life is assessed at baseline at 3 and 6 months and at 1 year
Patients are followed every 3-4 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 74 patients 37 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0279 | None | None | None |