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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 years for reporting.

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

~2310

Dactinomycin

2010

Completed Phase 3

~1310