Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer (NCT00002611) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
United States, Australia, Canada3,031 participantsStarted 1995-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer.
PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.
Who can participate
Age range
0 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed stage I-V kidney cancer of one of the following histologies:
* Wilms' tumor, favorable histology
* Wilms' tumor, focal or diffuse anaplastic
* Clear cell sarcoma
* Rhabdoid tumor
* (The rhabdoid tumor stratum closed to accrual effective 07/13/2001)
* Prior nephrectomy or biopsy required
* Prior bilateral biopsy (preferably open) with bilateral staging and pathologic evaluation required for bilateral tumor
* Must begin study therapy within 5 days after nephrectomy (unless medically contraindicated)
PATIENT CHARACTERISTICS:
Age:
* Under 16
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared chemotherapy alone versus chemotherapy combined with radiation therapy for children with kidney cancer — based on the results, does the evidence suggest one approach led to better progression-free survival, and would either approach be relevant to my child's specific situation?
2Since this was a Phase 3 trial that has already completed, has the data been published, and what did it show about the long-term risks of adding radiation therapy for a child's developing body?
3Radiation therapy in children can have serious long-term side effects depending on the area treated — given that this trial specifically studied that combination, what does my doctor know about how those risks compared to the benefits seen in progression-free survival?
4Are the treatment approaches tested in this completed trial now considered standard of care for pediatric kidney cancer, or have newer options emerged since the trial ended that my child's team would recommend instead?
5Given my child's age, kidney cancer type, and stage, would my doctor consider the chemotherapy regimens studied in this trial to be a reasonable starting point for discussion, or are there other current trials or treatments that might be a better fit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.