CompletedPhase 3

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

United States, Australia, Canada808 participantsStarted 2006-11-06

Plain-language summary

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

Who can participate

Age range

29 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.

Inclusion Criteria: * Histologically confirmed Wilms' tumor * Newly diagnosed stage I-III disease * Favorable histology * No moderate- or high-risk Wilms' predisposition syndromes * Must meet 1 of the following disease stratification categories: * Very low-risk disease * Stage I disease * Age \< 2 years * Tumor weight \< 550 g * Regional lymph nodes histologically negative (must have been sampled) * No pulmonary metastases on CT scan of chest * No synchronous bilateral Wilms tumors (Stage V) * Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following: * Aniridia * Beckwith-Wiedemann syndrome * Simpson-Golabi-Behmel syndrome * Denys-Drash syndrome or other associated genito-urinary anomalies * Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child \< 1 year of age * Diffuse hyperplastic perilobar nephroblastomatosis * Standard-risk disease meeting 1 of the following criteria: * Disease does not require radiotherapy * LOH at chromosomes 1p and 16q for stage I or II * Stage I disease meeting 1 of the following criteria: * Age ≥ 2 years to age \< 30 years * Tumor weight ≥ 500 g * Stage II disease * Age \< 30 years * Any tumor weight * Disease requires radiotherapy * No LOH at chromosomes 1p and 16q\* * Stage III disease * Must be enrolled on protocol C…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Event Free Survival Probability

Timeframe: 4 years

Overall Survival (OS) Probability

Timeframe: 4 years

Trial details

NCT IDNCT00352534

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2014-12-31

Results submitted2016-10-26

View on ClinicalTrials.gov More Stage I Kidney Wilms Tumor trials