This clinical trial is focused on studying a type of cancer known as Stage IV childhood renal tumor, which is a kidney cancer in children that has spread to other parts of the body, such as the lungs. The study is comparing two different treatment combinations to see which is more effective. The first treatment combination, known as the standard arm, includes the drugs Vincristine, Actinomycin-D, and Doxorubicin (VAD). The second treatment combination, called the experimental arm, includes Vincristine, Carboplatin, and Etoposide (VCE).
The purpose of the study is to determine if the experimental treatment (VCE) is not worse than the standard treatment (VAD) in terms of how well it works in shrinking the cancer before surgery. The study will involve giving the treatments to patients for a period of six weeks before surgery. During this time, doctors will monitor how the cancer responds to the treatments, particularly looking at how the cancer in the lungs and other areas responds.
Participants in the study will receive one of the two treatment combinations through an intravenous method, which means the medication is given directly into a vein. The study will help doctors understand which treatment is more effective in treating this type of cancer in children. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to improve the treatment options available for children with this serious condition.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age and the presence of a metastatic renal tumor.
The study involves a comparison between two treatment groups: the standard arm and the experimental arm.
2treatment group assignment
Participants are randomly assigned to one of two groups: the standard arm or the experimental arm.
The standard arm receives a combination of vincristine sulfate, doxorubicin hydrochloride, and dactinomycin (VAD).
The experimental arm receives a combination of vincristine sulfate, carboplatin, and etoposide (VCE).
3preoperative chemotherapy
Both groups undergo 6 weeks of preoperative chemotherapy.
Medications are administered intravenously, meaning they are given directly into a vein.
The goal is to assess the response of the tumor to the treatment.
4surgery
After the initial 6 weeks of chemotherapy, surgery is performed to remove the tumor.
The timing of the surgery may vary depending on the response to the chemotherapy and any side effects experienced.
5adjuvant chemotherapy
Following surgery, an additional 9 weeks of chemotherapy is administered.
This phase aims to eliminate any remaining cancer cells and reduce the risk of recurrence.
6follow-up and assessment
Regular follow-up visits are scheduled to monitor health and assess the effectiveness of the treatment.
Imaging tests and other assessments are conducted to evaluate the response to the treatment and check for any signs of cancer.
Who Can Join the Study?
Must be younger than 18 years old and older than 3 months.
Must have a metastatic renal tumor at the initial diagnosis. This means the kidney tumor has spread to other parts of the body.
Must have at least one nodule or lump in the lungs or another area that is at least 3 mm in size, as seen on a chest or abdominal scan. This nodule should not have calcium deposits and should be suspected of being a spread of the disease.
The spread of the disease must be confirmed by a central review, which means experts will check the diagnosis.
Must understand and willingly give permission to participate in the study. If the patient is a child, their parents or legal guardians must also agree.
Must be able to follow the schedule of visits and other study requirements.
Must not have any existing heart problems.
Must not have any existing liver problems that cannot be controlled with treatment.
The diagnosis of the metastatic childhood kidney tumor must be confirmed by a central review.
Who Cannot Join the Study?
Patients who do not have a Stage IV childhood renal tumor with spread to the lungs or other parts of the body cannot participate. A renal tumor is a type of kidney cancer, and Stage IV means it has spread beyond the kidney.
Patients who are not newly diagnosed with this condition are excluded. This means the study is only for those who have just found out they have this type of cancer.
Patients who are not within the specific age range required for the study cannot participate. The study is for children, so adults are not eligible.
Patients who are not able to follow the study procedures or take the study medications as required will be excluded. This means if someone cannot take the medicine or follow the rules of the study, they cannot join.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate will be excluded. This means if someone has another illness that could cause problems, they cannot be in the study.
Vincristine is a medication used in cancer treatment. It works by stopping the growth of cancer cells. In this trial, it is part of both the standard and experimental treatment groups.
Actinomycin-D is another cancer medication that helps to slow or stop the growth of cancer cells. It is used in the standard treatment group in this trial.
Doxorubicin is a chemotherapy drug that kills cancer cells by interfering with their DNA. It is included in the standard treatment group for this trial.
Carboplatin is a chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is part of the experimental treatment group in this trial.
Etoposide is a cancer treatment drug that helps to stop cancer cells from dividing. It is used in the experimental treatment group in this trial.
Stage IV Childhood Renal Tumor with Pulmonary and/or Non-Pulmonary Metastasis – This disease is a type of kidney cancer that occurs in children and has spread beyond the kidney to other parts of the body, such as the lungs or other organs. It is characterized by the presence of a primary tumor in the kidney and additional metastatic tumors in other locations. The progression involves the growth and spread of cancerous cells from the kidney to distant sites, which can complicate treatment and management. The disease is often identified by the presence of multiple tumors and may involve various histological subtypes. The spread to the lungs is common, and the disease can also affect other non-pulmonary sites. The condition is considered rare and requires specialized medical attention.
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