Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002611
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY
Status:
COMPLETED
Status Verified Date:
2014-07
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high energy x-rays to damage tumor cells It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer
PURPOSE Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer
PURPOSE Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer
Detailed Description:
OBJECTIVES
Increase survival rate of children with favorable histology FH Wilms tumor and other childhood renal tumors
Determine whether loss of heterozygosity for chromosome 16q or 1p in tumor tissue is associated with a poorer prognosis in children with FH Wilms tumor
Determine whether increased DNA content in tumor cells is associated with a poorer prognosis in children with FH Wilms tumor
Decrease the acute and long-term morbidity in children with Wilms tumor by limiting initial therapy and consistently using the same regimen protocol NWTS-5R for patients who relapse following initial treatment
Improve overall and disease-free survival of patients with renal tumors of unfavorable histology including Wilms tumor with diffuse anaplasia and clear cell sarcoma of the kidney using a new treatment regimen that includes etoposide VP-16 and cyclophosphamide CTX
Improve overall and disease-free survival in patients with malignant rhabdoid tumor of the kidney using a new treatment regimen that includes carboplatin VP-16 and CTX The rhabdoid tumor stratum closed to accrual effective 07132001
Provide data regarding loss of heterozygosity for chromosomes 11p15 16q and 1p age at diagnosis precursor lesions perilobar intralobar nephroblastomatosis bilaterality and presence of congenital anomalies required for the completion of protocol A0026 a case-control study of risk factors for Wilms tumor
OUTLINE This is a multicenter study Patients are assigned to one of nine strata based on tumor histology stage tumor weight and age
Stratum 1 stage I favorable histology FH Wilms tumor under 24 months of age and tumor weight less than 550 g After nephrectomy patients receive regimen EE-4A comprising dactinomycin DACT IV weekly on weeks 0 3 6 9 12 15 and 18 and vincristine VCR IV weekly on weeks 1-10 12 15 and 18
Stratum 2 stage I FH Wilms tumor and age 24 months and over or tumor weight at least 550 g stage I focal anaplastic FA or diffuse anaplastic DA Wilms tumor Patients receive therapy as in stratum 1
Stratum 3 stage II FH Wilms tumor Patients receive therapy as in stratum 1
Stratum 4 stage III FH Wilms tumor stage II or III FA Wilms tumor After nephrectomy patients receive regimen DD-4A comprising DACT IV weekly on weeks 0 6 12 18 and 24 doxorubicin IV weekly on weeks 3 9 15 and 21 and VCR IV weekly on weeks 1-10 12 15 18 21 and 24 Patients also undergo abdominal radiotherapy
Stratum 5 stage IV FH or FA Wilms tumor Patients receive chemotherapy as in stratum 4 abdominal radiotherapy and whole lung radiotherapy at the discretion of the investigator
Stratum 6 stage V FH FA or DA Wilms tumor After bilateral biopsy patients with FH receive chemotherapy as in stratum 1 or 4 Patients with FA or DA receive chemotherapy as in stratum 7
Stratum 7 stages I-IV clear cell sarcoma After nephrectomy patients receive VCR IV weekly on weeks 1 2 4-8 10-13 18 and 24 cyclophosphamide CTX IV over 1 hour on days 1-3 of weeks 6 12 18 and 24 and on days 1-5 of weeks 3 9 15 and 21 doxorubicin IV beginning after CTX infusion weekly on weeks 0 6 12 18 and 24 and etoposide VP-16 IV over 1 hour beginning after CTX infusion on days 1-5 of weeks 3 9 15 and 21 Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of chemotherapy and continuing until blood counts recover Patients also undergo abdominal radiotherapy and whole lung radiotherapy if pulmonary metastases are present
Stratum 8 stages II-IV DA Wilms tumor Patients receive treatment as in stratum 7
Stratum 9 stages I-IV rhabdoid tumor After nephrectomy patients receive carboplatin IV on days 1-2 and VP-16 IV over 1 hour beginning after carboplatin infusion on days 1-3 of weeks 0 3 9 12 18 and 21 and CTX IV over 1 hour on days 1-5 of weeks 6 15 and 24 G-CSF is administered as in stratum 7 Patients also undergo radiotherapy The rhabdoid tumor stratum closed to accrual effective 07132001 After completion of chemotherapy patients undergo second-look laparotomy and partial nephrectomy or wedge excision if feasible After second-look surgery patients without persistent or residual disease resume chemotherapy
Patients are followed every 3 months for 5 years every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 207 patients will be accrued for the treatment portion of this study The rhabdoid tumor stratum closed to accrual effective 07132001
Increase survival rate of children with favorable histology FH Wilms tumor and other childhood renal tumors
Determine whether loss of heterozygosity for chromosome 16q or 1p in tumor tissue is associated with a poorer prognosis in children with FH Wilms tumor
Determine whether increased DNA content in tumor cells is associated with a poorer prognosis in children with FH Wilms tumor
Decrease the acute and long-term morbidity in children with Wilms tumor by limiting initial therapy and consistently using the same regimen protocol NWTS-5R for patients who relapse following initial treatment
Improve overall and disease-free survival of patients with renal tumors of unfavorable histology including Wilms tumor with diffuse anaplasia and clear cell sarcoma of the kidney using a new treatment regimen that includes etoposide VP-16 and cyclophosphamide CTX
Improve overall and disease-free survival in patients with malignant rhabdoid tumor of the kidney using a new treatment regimen that includes carboplatin VP-16 and CTX The rhabdoid tumor stratum closed to accrual effective 07132001
Provide data regarding loss of heterozygosity for chromosomes 11p15 16q and 1p age at diagnosis precursor lesions perilobar intralobar nephroblastomatosis bilaterality and presence of congenital anomalies required for the completion of protocol A0026 a case-control study of risk factors for Wilms tumor
OUTLINE This is a multicenter study Patients are assigned to one of nine strata based on tumor histology stage tumor weight and age
Stratum 1 stage I favorable histology FH Wilms tumor under 24 months of age and tumor weight less than 550 g After nephrectomy patients receive regimen EE-4A comprising dactinomycin DACT IV weekly on weeks 0 3 6 9 12 15 and 18 and vincristine VCR IV weekly on weeks 1-10 12 15 and 18
Stratum 2 stage I FH Wilms tumor and age 24 months and over or tumor weight at least 550 g stage I focal anaplastic FA or diffuse anaplastic DA Wilms tumor Patients receive therapy as in stratum 1
Stratum 3 stage II FH Wilms tumor Patients receive therapy as in stratum 1
Stratum 4 stage III FH Wilms tumor stage II or III FA Wilms tumor After nephrectomy patients receive regimen DD-4A comprising DACT IV weekly on weeks 0 6 12 18 and 24 doxorubicin IV weekly on weeks 3 9 15 and 21 and VCR IV weekly on weeks 1-10 12 15 18 21 and 24 Patients also undergo abdominal radiotherapy
Stratum 5 stage IV FH or FA Wilms tumor Patients receive chemotherapy as in stratum 4 abdominal radiotherapy and whole lung radiotherapy at the discretion of the investigator
Stratum 6 stage V FH FA or DA Wilms tumor After bilateral biopsy patients with FH receive chemotherapy as in stratum 1 or 4 Patients with FA or DA receive chemotherapy as in stratum 7
Stratum 7 stages I-IV clear cell sarcoma After nephrectomy patients receive VCR IV weekly on weeks 1 2 4-8 10-13 18 and 24 cyclophosphamide CTX IV over 1 hour on days 1-3 of weeks 6 12 18 and 24 and on days 1-5 of weeks 3 9 15 and 21 doxorubicin IV beginning after CTX infusion weekly on weeks 0 6 12 18 and 24 and etoposide VP-16 IV over 1 hour beginning after CTX infusion on days 1-5 of weeks 3 9 15 and 21 Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of chemotherapy and continuing until blood counts recover Patients also undergo abdominal radiotherapy and whole lung radiotherapy if pulmonary metastases are present
Stratum 8 stages II-IV DA Wilms tumor Patients receive treatment as in stratum 7
Stratum 9 stages I-IV rhabdoid tumor After nephrectomy patients receive carboplatin IV on days 1-2 and VP-16 IV over 1 hour beginning after carboplatin infusion on days 1-3 of weeks 0 3 9 12 18 and 21 and CTX IV over 1 hour on days 1-5 of weeks 6 15 and 24 G-CSF is administered as in stratum 7 Patients also undergo radiotherapy The rhabdoid tumor stratum closed to accrual effective 07132001 After completion of chemotherapy patients undergo second-look laparotomy and partial nephrectomy or wedge excision if feasible After second-look surgery patients without persistent or residual disease resume chemotherapy
Patients are followed every 3 months for 5 years every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 207 patients will be accrued for the treatment portion of this study The rhabdoid tumor stratum closed to accrual effective 07132001
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 |
|---|---|---|---|
| COG-Q9401 | OTHER | None | None |
| NWTS-Q9401 | OTHER | None | None |
| CCG-4941 | OTHER | None | None |
| POG-9440 | OTHER | None | None |
| INT-0150 | None | None | None |
| NWTS-5 | OTHER | None | None |
| CDR0000063901 | OTHER | NCI | None |