Chemotherapy +/− Radiation for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of chemotherapy drugs, such as vincristine, dactinomycin (also known as Actinomycin D or Cosmegen), and doxorubicin, with or without radiation after surgery for treating Wilms' tumor, a type of kidney cancer. The aim is to determine if these treatments effectively eliminate remaining cancer cells and prevent tumor recurrence. Participants may qualify if they have recently been diagnosed with stage I, II, or III Wilms' tumor and have not received prior chemotherapy or radiation. The trial includes various treatment plans based on risk levels, ranging from observation after surgery to a combination of chemotherapy and radiation. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking cancer treatment advancements.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the chemotherapy drugs used in this trial—vincristine, dactinomycin, and doxorubicin—have been well-studied for safety. Each drug has its own side effects, but they are often combined to treat certain types of cancer.
Vincristine stops cancer cells from growing. It can cause constipation and stomach pain, and in some cases, might lead to an intestinal blockage. The FDA has approved it for treating several types of cancer.
Dactinomycin treats cancers like Wilms’ tumor and is FDA approved for these uses. It can affect the liver, kidneys, and bone marrow, which are crucial for filtering blood and fighting infections.
Doxorubicin is another well-known cancer drug. It can cause severe tissue damage if it leaks from the vein during injection. There is also a risk of developing new cancers after using it. Despite this, it is commonly used because it is effective.
Research indicates that radiation therapy is generally safe and doesn't cause many severe side effects.
In this study phase, these treatments have been tested in many patients, demonstrating their safety. However, like any treatment, they can still have side effects. Anyone considering this trial should weigh these risks and consult with their healthcare team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine chemotherapy and radiation in a novel way to target kidney cancer. Unlike standard treatments that might use only surgery or traditional chemotherapy, this approach tailors treatment based on risk and disease stage. In Stratum I, very low-risk patients are monitored closely, with surgery and chemo reserved for those who need it, minimizing unnecessary exposure to treatments. Stratum II and III patients receive a strategic mix of vincristine, dactinomycin, and doxorubicin, with the addition of radiation for those in Stratum III, aiming for a more aggressive attack on the cancer cells. This personalized strategy hopes to improve outcomes while reducing side effects.
What evidence suggests that this trial's treatments could be effective for Wilms' tumor?
In this trial, participants with kidney cancer will be assigned to different treatment arms. Research has shown that a combination of three drugs—vincristine, dactinomycin, and doxorubicin—can effectively treat Wilms' tumor. These medications kill cancer cells or stop them from growing and spreading. Some participants will receive this drug combination alongside surgery, which studies have shown reliably shrinks the tumor and prevents further growth. Additionally, certain arms may use radiation therapy, which employs high-energy rays to destroy any remaining cancer cells after surgery. This treatment plan offers a strong chance of effectively fighting the cancer. Overall, these methods have shown promising results in managing Wilms' tumor.56789
Who Is on the Research Team?
Elizabeth A Mullen
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for young patients who've had surgery for a newly diagnosed Wilms' tumor, which is a type of kidney cancer. It's open to those with stage I-III disease, under 30 years old, and without certain genetic syndromes or bilateral tumors. Patients must not be pregnant, should use contraception if fertile, and have not received prior tumor treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Patients undergo nephrectomy or biopsy as part of the initial treatment procedure
Treatment
Patients receive chemotherapy with vincristine, dactinomycin, and doxorubicin, and may undergo radiotherapy
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
- 3-Dimensional Conformal Radiation Therapy
- Dactinomycin
- Doxorubicin Hydrochloride
- Therapeutic Conventional Surgery
- Vincristine Sulfate
Dactinomycin is already approved in United States, European Union, Canada for the following indications:
- Rhabdomyosarcoma
- Ewing sarcoma
- Wilms tumor
- Troophoblastic neoplasm
- Rhabdomyosarcoma
- Ewing sarcoma
- Wilms tumor
- Troophoblastic neoplasm
- Rhabdomyosarcoma
- Ewing sarcoma
- Wilms tumor
- Troophoblastic neoplasm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator