Chemotherapy + Radiation for Kidney Cancer (Wilms' Tumor)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of combining chemotherapy and radiation therapy for young patients with newly diagnosed Wilms' tumor, a type of kidney cancer. The goal is to determine if multiple chemotherapy drugs, with or without radiation, can kill more cancer cells. The trial includes various treatment plans and may involve surgery and radiation for those with specific types of tumor spread. It is designed for patients recently diagnosed with stage III or IV Wilms' tumor after surgery or biopsy. Participants must not have cancer in both kidneys or have received prior tumor treatments unless transferring from a specific previous trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take aprepitant while participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the drugs used in this study effectively treat various cancers, including Wilms' tumor. Here is a simplified overview of their safety records:
Cyclophosphamide, a chemotherapy drug for many cancer types, can cause side effects like infertility and birth defects but is generally safe when taken as prescribed.
Dactinomycin is used in children's cancers, including Wilms' tumor. It is very strong and handled with care, but it has proven effective for this cancer.
Doxorubicin hydrochloride can cause cancer cells to break down quickly, potentially leading to tumor lysis syndrome, a serious side effect that can be managed with medical care.
Etoposide is used for other cancers and is usually well-tolerated, though it can cause side effects such as low blood cell counts.
Liposomal vincristine sulfate, a newer version of vincristine, targets cancer cells more effectively. It allows for higher doses without increasing side effects like nerve damage, a common concern with vincristine.
Overall, these treatments have been thoroughly studied and are commonly used for Wilms' tumor. Their safety profiles are well-known, and while risks exist, they are carefully managed in a controlled clinical trial setting.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment for Wilms' Tumor because it combines chemotherapy and radiation in a way that targets cancer more aggressively. Unlike the standard treatment, which often involves surgery followed by chemotherapy, this approach uses a mix of drugs like cyclophosphamide, dactinomycin, doxorubicin hydrochloride, etoposide, and liposomal vincristine sulfate. These drugs are given in different phases, with the inclusion of radiation therapy, especially for patients with metastases, aiming to improve outcomes. The potential of this regimen to shrink tumors more effectively and reduce the chance of recurrence is what makes it stand out.
What evidence suggests that this trial's treatments could be effective for Wilms' tumor?
Research shows that the drugs used in this trial hold promise for treating Wilms' tumor. In similar studies, cyclophosphamide and etoposide have helped 79% of patients avoid major health events for five years and 90% of patients survive overall. In this trial, some participants will receive a regimen including cyclophosphamide. Doxorubicin, part of the treatment regimen in this trial, improved outcomes for Stage III Wilms' tumor, with 84% of patients not experiencing a return of the tumor for eight years. Dactinomycin, also included in the trial, has been part of successful treatments for Wilms' tumor over the years. Liposomal vincristine sulfate, another drug in the trial, allows for higher doses without more side effects, potentially leading to better results. Radiation therapy, when combined with chemotherapy, has effectively improved survival rates, with over 90% of children becoming long-term survivors.678910
Who Is on the Research Team?
David B Dix
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Regimen DD4A (Initial)
Participants receive dactinomycin, vincristine, and doxorubicin hydrochloride. Radiotherapy is administered for patients with pulmonary and extra-pulmonary metastases.
Treatment - Regimen DD4A or M
Participants continue with either Regimen DD4A or switch to Regimen M based on response. Regimen DD4A includes dactinomycin, vincristine, and doxorubicin hydrochloride. Regimen M includes cyclophosphamide, etoposide, vincristine, dactinomycin, and doxorubicin hydrochloride, with whole lung radiotherapy for certain patients.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 3-dimensional Conformal Radiation Therapy
- Cyclophosphamide
- Dactinomycin
- Doxorubicin Hydrochloride
- Etoposide
- Liposomal Vincristine Sulfate
Trial Overview
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.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
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.
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
NCT00379340 | Combination Chemotherapy With or ...
This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed ...
Post‐operative flank irradiation using conformal versus ...
Five-year overall survival (OS) has increased to over 90%. However, the incidence of recurrence remains around 15%. Nowadays, the treatment ...
Inter-clinician delineation variation for a new highly-conformal ...
A total of 57/60 delineation sets were completed. The median DSCref/part for the CTV was 0.55 without improvement after sequential cases (case 3 ...
Wilms' tumor: Changing role of radiation therapy
Wilms' tumor is a highly curable neoplasm. Greater than 90% of all children with this disease can be expected to become long-term survivors.
UCSF Wilms Tumor Trial → Vincristine, Dactinomycin, and ...
Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments ...
Wilms Tumor and Other Childhood Kidney ...
The addition of cyclophosphamide at the protocol dose (10 mg/kg/d for 3 days every 6 weeks) to the combination of vincristine, dactinomycin, and ...
Impact of Cyclophosphamide and Etoposide on Outcome of ...
The outcome for patients with CCSK treated on NWTS-5 was similar to NWTS-4 and accomplished over a shorter treatment duration.
Cyclophosphamide: Uses, Interactions, Mechanism of Action
Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer. Modality: Small Molecule; Groups: Approved, Investigational; Structure. 3D.
Cyclophosphamide: Uses, Side Effects & Dosage
Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth.
Wilms Tumor, Version 2.2025, NCCN Clinical Practice ...
Data suggested that certain molecular markers in the tumors could be used to identify children who might be at higher risk after surgery alone; ...
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