Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003804
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms Tumor
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Nephroblastoma Clinical Trial and Study
Status:
UNKNOWN
Status Verified Date:
2012-04
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die It is not yet known which regimen of chemotherapy is more effective for stage I Wilms tumor
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms tumor
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms tumor
Detailed Description:
OBJECTIVES I Determine the initial extension of disease surgical procedures gross and histological morphology treatments clinical outcome and late consequences of therapy after treatment with neoadjuvant chemotherapy surgery and adjuvant chemotherapy with or without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I Wilms tumor II Determine the safety and effectiveness of reduced chemotherapy in these patients
OUTLINE This is a randomized multicenter study Patients receive dactinomycin IV on days 1-3 and 15-17 and vincristine IV on days 1 8 15 and 22 Patients then undergo surgery about a week after completion of chemotherapy After surgery patients receive vincristine IV on days 1 8 15 and 22 and dactinomycin IV on days 8-12 Patients are then randomized to one of two treatment arms after week 9 Arm I Patients receive dactinomycin IV on days 1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11 This course is repeated during weeks 17 and 18 Arm II Patients receive no further treatment Patients are followed every 3 months for 3 years then annually thereafter Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients 175 per treatment arm will be accrued for this study within 7-8 years
OUTLINE This is a randomized multicenter study Patients receive dactinomycin IV on days 1-3 and 15-17 and vincristine IV on days 1 8 15 and 22 Patients then undergo surgery about a week after completion of chemotherapy After surgery patients receive vincristine IV on days 1 8 15 and 22 and dactinomycin IV on days 8-12 Patients are then randomized to one of two treatment arms after week 9 Arm I Patients receive dactinomycin IV on days 1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11 This course is repeated during weeks 17 and 18 Arm II Patients receive no further treatment Patients are followed every 3 months for 3 years then annually thereafter Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients 175 per treatment arm will be accrued for this study within 7-8 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 |
|---|---|---|---|
| EU-98064 | None | None | None |
| SIOP-93-01 | None | None | None |