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
Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Wilms' Tumor
NCT ID: NCT00352534
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 07-008
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. PURPOSE: 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.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Massachusetts General Hospital
Overall PI:
Mary Huang, MD,
Massachusetts General Hospital
Site-responsible Investigators:
Elizabeth Mullen, MD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
DISEASE CHARACTERISTICS:
- 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
- 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 NOTE: *Patients with combined loss of heterozygosity
at chromosomes 1p and 16q will be eligible to transfer to protocol
COG-AREN0533
- Must be enrolled on protocol COG-AREN03B2
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- No prior tumor-directed chemotherapy or radiotherapy
- Patients transferring from AREN03B2 with LOH 1p and 16q allowed