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Alkylating agents
Chemotherapy + Radiation for Kidney Cancer (Wilms' Tumor)
Phase 3
Waitlist Available
Led By David Dix, MD
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
No concurrent aprepitant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is studying how well combo chemo with or without radiation therapy works to treat young patients newly diagnosed with stage III or stage IV Favorable Histology Wilms' tumor.
Who is the study for?
This trial is for young patients with a new diagnosis of stage III or IV Wilms' tumor. They must start treatment within two weeks after surgery or biopsy, have acceptable liver function and heart performance, and not be pregnant or breastfeeding. Those who've had prior tumor treatments (except in specific circumstances) can't join.
What is being tested?
The study is examining the effectiveness of combination chemotherapy with drugs like Doxorubicin Hydrochloride and Vincristine Sulfate Liposome, either alone or combined with radiation therapy, to see if this approach better kills cancer cells in children with advanced kidney tumors.
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, hair loss, mouth sores, increased risk of infection due to low blood cell counts. Radiation therapy might lead to skin irritation at the treated site and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can perform most of my daily activities without assistance.
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I am not currently taking aprepitant.
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I have been recently diagnosed with Wilms' tumor at a specific stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event Free Survival (EFS) Probability
Event Free Survival Probability
Secondary study objectives
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, surgery, radiotherapy)Experimental Treatment7 Interventions
REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy.
Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M.
REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV.
REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Dactinomycin
2010
Completed Phase 3
~1310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Conventional Surgery
2006
Completed Phase 3
~1080
Etoposide
2010
Completed Phase 3
~2960
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,435 Total Patients Enrolled
1 Trials studying Kidney Wilms Tumor
8,000 Patients Enrolled for Kidney Wilms Tumor
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,442 Total Patients Enrolled
1 Trials studying Kidney Wilms Tumor
8,000 Patients Enrolled for Kidney Wilms Tumor
David Dix, MDPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can perform most of my daily activities without assistance.You must have a negative pregnancy test.I am not currently taking aprepitant.Your liver enzymes (AST or ALT) are not more than 2.5 times the normal level.I haven't had chemotherapy or radiotherapy, except as part of COG-AREN0532 or for urgent medical reasons.I have been recently diagnosed with Wilms' tumor at a specific stage.Your bilirubin levels are within a certain range.I will start treatment within 2 weeks after my surgery or biopsy, unless my doctor advises against it.Your heart's pumping function is normal, as shown by specific heart tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, surgery, radiotherapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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