Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00352534
Eligibility Criteria:
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 COG-AREN03B2
* Karnofsky performance status (PS) 50-100% for patients \> 16 years old
* Lansky PS 50-100% for patients ≤ 16 years old
* Bilirubin (direct) ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram (standard-risk disease)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patient must use effective contraception
* No prior tumor-directed chemotherapy or radiotherapy
* Patients transferring from AREN03B2 with LOH 1p and 16q allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
29 Years
Study:
NCT00352534
Study Brief:
Protocol Section:
NCT00352534