Phase 3
N=808
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
Stage I Kidney Wilms Tumor · Stage II Kidney Wilms Tumor · Stage III Kidney Wilms Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00352534 ↗Enrolled (actual)
808
Serious AEs
2.7%
Results posted
May 2017
Primary outcome: Primary: Event Free Survival Probability — 0.88; 0.87; 0.88 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Biospecimen Collection (Procedure); Chest Radiography (Procedure); Computed Tomography (Procedure); Dactinomycin (Biological); Doxorubicin Hydrochloride (Drug); Echocardiography Test (Procedure); Magnetic Resonance Imaging (Procedure); Therapeutic Conventional Surgery (Procedure); Ultrasound Imaging (Procedure); Vincristine Sulfate (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival Probability |
0.88; 0.87; 0.88 | — |
| PRIMARY Overall Survival (OS) Probability |
1.00; 1.00; 0.97 | — |
| SECONDARY Incidence of Contralateral Kidney Lesions |
1 | — |
| SECONDARY Incidence of Renal Failure |
— | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00352534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.