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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 prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 haven't had chemotherapy or radiotherapy, except as part of COG-AREN0532 or for urgent medical reasons.
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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.
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I will start treatment within 2 weeks after my surgery or biopsy, unless my doctor advises against it.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event Free Survival (EFS) Probability
Event Free Survival Probability
Secondary outcome measures
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease

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
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Conventional Surgery
2006
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3780
Dactinomycin
2010
Completed Phase 3
~1310
Etoposide
2010
Completed Phase 3
~2440
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,005 Total Patients Enrolled
1 Trials studying Kidney Wilms Tumor
8,000 Patients Enrolled for Kidney Wilms Tumor
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,251 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

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00379340 — Phase 3
Kidney Wilms Tumor Research Study Groups: Treatment (chemotherapy, surgery, radiotherapy)
Kidney Wilms Tumor Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00379340 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00379340 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the primary conditions that cyclophosphamide is used to treat?

"While most commonly used as a treatment for lung cancer, cyclophosphamide can also be taken to help manage small cell lung cancer (sclc), multiple sclerosis, leukemia, myelocytic and acute conditions."

Answered by AI

Are there many research facilities conducting this trial throughout America?

"There are 100 different clinical trial sites currently enrolling patients for this study. While Columbus, Dallas and New york have participating locations, there are also many other places that you can choose from to minimize the amount of travel required."

Answered by AI

What are the predecessors of this experiment?

"Alfacell conducted the first study on cyclophosphamide in 1997 and, after a Phase 3 drug approval, there are currently 1189 active trials for this medication across 74 countries and 2555 cities."

Answered by AI

Are there any unfilled appointments in this clinical trial?

"The latest update on clinicaltrials.gov reveals that this trial is not currently looking for patients to enroll. That being said, there are still 3657 other trials recruiting individuals for medical studies."

Answered by AI

How many people are taking part in this clinical trial?

"This particular clinical trial is no longer recruiting patients. First posted on February 26th, 2007 and last updated on March 23rd, 20212, the study has finished admitting participants. However, there are 2468 other trials actively recruiting stage iv wilms tumor patients and 1189 cyclophosphamide trials currently underway."

Answered by AI

What are the most similar previous studies to this one involving cyclophosphamide?

"There are 1189 clinical trials currently underway that involve the use of cyclophosphamide. Out of these, 252 have reached Phase 3. Additionally, there are 43519 locations worldwide where these trials are taking place."

Answered by AI

Are there any notable risks associated with cyclophosphamide?

"Cyclophosphamide's safety is well-documented, as this drug has completed Phase 3 clinical trials."

Answered by AI
Recent research and studies
~22 spots leftby Mar 2025