Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098878
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2004-12-08
Brief Title:
Carboplatin in Treating Patients With Stage IC-IV Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
SCOTROC 4 A Prospective Multicentre Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian Fallopian Tube And Primary Peritoneal Cancers
Status:
COMPLETED
Status Verified Date:
2009-07
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 carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC stage II stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
PURPOSE This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC stage II stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Primary
Compare progression-free survival of patients with stage IC-IV ovarian epithelial fallopian tube or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy
Secondary
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare overall clinical response rate and CA 125 response in patients treated with these regimens
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a flat dose of carboplatin on day 1
Arm II Patients receive intra-patient dose-escalated carboplatin on day 1 In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each treatment course and then at 2 months post-chemotherapy
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1300 patients 650 per treatment arm will be accrued for this study
Primary
Compare progression-free survival of patients with stage IC-IV ovarian epithelial fallopian tube or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy
Secondary
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare overall clinical response rate and CA 125 response in patients treated with these regimens
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a flat dose of carboplatin on day 1
Arm II Patients receive intra-patient dose-escalated carboplatin on day 1 In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each treatment course and then at 2 months post-chemotherapy
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1300 patients 650 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| ISRCTN47645935 | REGISTRY | ISRCTN International Standard Randomised Controlled Trial Number Register | None |
| CDR0000396778 | REGISTRY | None | None |
| EU-20402 | None | None | None |