Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2006-07-13
Brief Title:
Vincristine Dactinomycin and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I Stage II or Stage III Wilms Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This phase III trial is studying vincristine dactinomycin and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I stage II or stage III Wilms tumor Drugs used in chemotherapy such as vincristine dactinomycin and doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing or by stopping them from spreading Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumorsGiving these treatments after surgery may kill any tumor cells that remain after surgery Sometimes after surgery the tumor may not need additional treatment until it progresses In this case observation may be sufficient
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms tumor 2 years of age and 550gms treated with nephrectomy only very low risk or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine dactinomycin doxorubicin hydrochloride and radiotherapy standard risk
SECONDARY OBJECTIVES
I Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker
II Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only
III Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse
IV Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2
OUTLINE This is a multicenter study Patients are stratified according to clinical and biological risk factors very low risk vs standard risk
STRATUM I very low-risk disease Patients undergo nephrectomy only If they meet criteria they are then observed periodically for 5 years Patients with recurrent disease undergo surgery immediate or delayed and receive chemotherapy as in stratum III Patients with no metachronous renal disease receive radiotherapy Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III but no radiotherapy Treatment continues for up to 25 weeks
STRATUM II standard-risk stage I or II disease with adverse biological marker Patients undergo nephrectomy Between 9 and 14 days post-nephrectomy patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses Patients receive dactinomycin IV beginning day 1 alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin Treatment continues for up to 25 weeks
STRATUM III standard-risk stage III disease Patients undergo nephrectomy if feasible or biopsy For patients who undergo biopsy only definitive surgery is undertaken at week 7 or 13 Between 9 and 14 days post-nephrectomy patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses Patients receive dactinomycin IV beginning day 1 alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride Patients undergo radiotherapy over 5-7 days after nephrectomy Treatment continues for up to 25 weeks
Additionally patients undergo chest X-ray computed tomography CT or magnetic resonance imaging MRI ultrasound echocardiography and blood sample collection throughout the study
After completion of study treatment patients are followed periodically for up to 8 years
I Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms tumor 2 years of age and 550gms treated with nephrectomy only very low risk or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine dactinomycin doxorubicin hydrochloride and radiotherapy standard risk
SECONDARY OBJECTIVES
I Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker
II Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only
III Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse
IV Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2
OUTLINE This is a multicenter study Patients are stratified according to clinical and biological risk factors very low risk vs standard risk
STRATUM I very low-risk disease Patients undergo nephrectomy only If they meet criteria they are then observed periodically for 5 years Patients with recurrent disease undergo surgery immediate or delayed and receive chemotherapy as in stratum III Patients with no metachronous renal disease receive radiotherapy Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III but no radiotherapy Treatment continues for up to 25 weeks
STRATUM II standard-risk stage I or II disease with adverse biological marker Patients undergo nephrectomy Between 9 and 14 days post-nephrectomy patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses Patients receive dactinomycin IV beginning day 1 alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin Treatment continues for up to 25 weeks
STRATUM III standard-risk stage III disease Patients undergo nephrectomy if feasible or biopsy For patients who undergo biopsy only definitive surgery is undertaken at week 7 or 13 Between 9 and 14 days post-nephrectomy patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses Patients receive dactinomycin IV beginning day 1 alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride Patients undergo radiotherapy over 5-7 days after nephrectomy Treatment continues for up to 25 weeks
Additionally patients undergo chest X-ray computed tomography CT or magnetic resonance imaging MRI ultrasound echocardiography and blood sample collection throughout the study
After completion of study treatment patients are followed periodically for up to 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 |
|---|---|---|---|
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |
| NCI-2009-01067 | REGISTRY | None | None |
| 06-936 | None | None | None |
| AREN0532 | None | None | None |
| CDR0000487540 | None | None | None |
| AREN0532 | OTHER | None | None |
| AREN0532 | OTHER | None | None |
| U10CA098543 | NIH | None | None |