Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047138
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2002-10-03
Brief Title:
Chemotherapy Before and After Surgery in Treating Children With Wilms Tumor
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Nephroblastoma Wilms Tumour Clinical Trial And Study
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
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 tumor cells from dividing so they stop growing or die Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery Giving more chemotherapy after surgery may kill any remaining tumor cells It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilms tumor
PURPOSE Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilms tumor
PURPOSE Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilms tumor
Detailed Description:
OBJECTIVES
Determine the response rate in children with Wilms tumor treated with pre-operative chemotherapy
Compare the response rate in children with intermediate-risk stage II or III Wilms tumor treated with or without doxorubicin after surgery
Determine the prognostic significance of histological subtypes in these patients after pre-operative chemotherapy
Determine whether reduced treatment minimizes acute and late toxicity without jeopardizing event-free and overall survival in patients with focal anaplasia or intermediate-risk stage I Wilms tumor
Determine the prognostic significance of tumor volume and specimen weight after pre-operative chemotherapy and its relation to histological subtype in these patients
Determine the effect of single-dose dactinomycin as pre-operative chemotherapy in these patients
Correlate allele loss at 16q 1p and other chromosomal regions with relapse-free and overall survival of patients treated with these regimens
Correlate allele losses with clinical risk factors eg histological appearance and tumor volume after pre-operative chemotherapy in these patients
Determine laboratory indicators of myocardial damage in patients treated with these regimens
Determine the prognostic significance of the percentage of necrosis after pre-operative chemotherapy in terms of type and amount of residual viable tumor in these patients
OUTLINE This is a partially randomized multicenter study Patients are stratified according to country and participating center Patients with intermediate-risk stage II or III disease are further stratified according to histology blastemal vs epithelial vs stromal vs mixed
Patients with localized disease receive neoadjuvant therapy comprising vincristine IV on days 1 8 15 and 22 and dactinomycin IV on days 1 and 15
Patients undergo surgery during weeks 5 or 6
Patients with low-risk stage I disease receive no further therapy
Adjuvant chemotherapy begins after surgery and within 21 days of last dose of neoadjuvant chemotherapy
Patients with intermediate-risk stage I disease receive vincristine IV on days 1 8 15 and 22 and dactinomycin IV on day 7
Patients with intermediate-risk stage II or III disease are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV weekly for 8 weeks and then on days 1 and 7 of weeks 11 14 17 20 23 and 26 Patients also receive dactinomycin IV weekly on weeks 2 5 8 11 14 17 20 23 and 26 and doxorubicin IV over 4-6 hours weekly on weeks 2 8 14 20 and 26
Arm II Patients receive vincristine and dactinomycin as in arm I Patients with high-risk stage I disease receive chemotherapy as in arm I Patients with low-risk stage II disease receive chemotherapy as in arm II
Patients with high-risk stage II or III disease receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 on weeks 1 7 13 19 25 and 31 Patients also receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 on weeks 4 10 16 22 28 and 34
Patients with intermediate-risk stage III or high-risk stage II or III disease also undergo radiotherapy for approximately 3 weeks during chemotherapy
Patients with metastatic disease receive neoadjuvant chemotherapy comprising vincristine IV on day 1 of weeks 1-6 dactinomycin IV on day 1 of weeks 1 3 and 5 and doxorubicin IV over 4-6 hours on day 1 of weeks 1 and 5
Patients undergo surgery during week 7
Within 2 weeks of surgery patients receive 1 of the following adjuvant chemotherapy regimens
Regimen A no metastases or completely resected Patients receive vincristine IV weekly for 8 weeks and then on weeks 11 12 14 15 17 18 20 21 23 24 26 and 27 Patients also receive dactinomycin IV on day 1 of weeks 2 5 8 11 14 17 20 23 and 26 and doxorubicin IV over 4-6 hours on weeks 2 8 14 and 20 Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks
Regimen B multiple inoperable metastases incomplete resection or high-risk primary disease Patients receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 of weeks 4 10 13 16 22 25 28 and 34 Patients also receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 of weeks 1 7 19 and 31 Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks
Patients are followed every 2-3 months for 2 years every 3-6 months for 1-2 years and then every 6-12 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients 174 per treatment arm will be accrued for the randomized portion of this study within 7 years
Determine the response rate in children with Wilms tumor treated with pre-operative chemotherapy
Compare the response rate in children with intermediate-risk stage II or III Wilms tumor treated with or without doxorubicin after surgery
Determine the prognostic significance of histological subtypes in these patients after pre-operative chemotherapy
Determine whether reduced treatment minimizes acute and late toxicity without jeopardizing event-free and overall survival in patients with focal anaplasia or intermediate-risk stage I Wilms tumor
Determine the prognostic significance of tumor volume and specimen weight after pre-operative chemotherapy and its relation to histological subtype in these patients
Determine the effect of single-dose dactinomycin as pre-operative chemotherapy in these patients
Correlate allele loss at 16q 1p and other chromosomal regions with relapse-free and overall survival of patients treated with these regimens
Correlate allele losses with clinical risk factors eg histological appearance and tumor volume after pre-operative chemotherapy in these patients
Determine laboratory indicators of myocardial damage in patients treated with these regimens
Determine the prognostic significance of the percentage of necrosis after pre-operative chemotherapy in terms of type and amount of residual viable tumor in these patients
OUTLINE This is a partially randomized multicenter study Patients are stratified according to country and participating center Patients with intermediate-risk stage II or III disease are further stratified according to histology blastemal vs epithelial vs stromal vs mixed
Patients with localized disease receive neoadjuvant therapy comprising vincristine IV on days 1 8 15 and 22 and dactinomycin IV on days 1 and 15
Patients undergo surgery during weeks 5 or 6
Patients with low-risk stage I disease receive no further therapy
Adjuvant chemotherapy begins after surgery and within 21 days of last dose of neoadjuvant chemotherapy
Patients with intermediate-risk stage I disease receive vincristine IV on days 1 8 15 and 22 and dactinomycin IV on day 7
Patients with intermediate-risk stage II or III disease are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV weekly for 8 weeks and then on days 1 and 7 of weeks 11 14 17 20 23 and 26 Patients also receive dactinomycin IV weekly on weeks 2 5 8 11 14 17 20 23 and 26 and doxorubicin IV over 4-6 hours weekly on weeks 2 8 14 20 and 26
Arm II Patients receive vincristine and dactinomycin as in arm I Patients with high-risk stage I disease receive chemotherapy as in arm I Patients with low-risk stage II disease receive chemotherapy as in arm II
Patients with high-risk stage II or III disease receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 on weeks 1 7 13 19 25 and 31 Patients also receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 on weeks 4 10 16 22 28 and 34
Patients with intermediate-risk stage III or high-risk stage II or III disease also undergo radiotherapy for approximately 3 weeks during chemotherapy
Patients with metastatic disease receive neoadjuvant chemotherapy comprising vincristine IV on day 1 of weeks 1-6 dactinomycin IV on day 1 of weeks 1 3 and 5 and doxorubicin IV over 4-6 hours on day 1 of weeks 1 and 5
Patients undergo surgery during week 7
Within 2 weeks of surgery patients receive 1 of the following adjuvant chemotherapy regimens
Regimen A no metastases or completely resected Patients receive vincristine IV weekly for 8 weeks and then on weeks 11 12 14 15 17 18 20 21 23 24 26 and 27 Patients also receive dactinomycin IV on day 1 of weeks 2 5 8 11 14 17 20 23 and 26 and doxorubicin IV over 4-6 hours on weeks 2 8 14 and 20 Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks
Regimen B multiple inoperable metastases incomplete resection or high-risk primary disease Patients receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 of weeks 4 10 13 16 22 25 28 and 34 Patients also receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 of weeks 1 7 19 and 31 Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks
Patients are followed every 2-3 months for 2 years every 3-6 months for 1-2 years and then every 6-12 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients 174 per treatment arm will be accrued for the randomized portion of this study within 7 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 |
|---|---|---|---|
| EU-20208 | None | None | None |
| SIOP-WT-2001 | None | None | None |
| SFOP-SIOP-WT-2001 | None | None | None |
| CCLG-SIOP-WT-2001 | None | None | None |
| GPOH-GERMANY-SIOP-WT-2001 | None | None | None |