NCT00379340

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT00379340

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Summary

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy 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 more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Eligibility

Inclusion Criteria:

* Newly diagnosed Wilms' tumor meeting 1 of the following criteria:

* Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
* Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
* Patients must begin therapy within 14 days after surgery or biopsy, unless medically contraindicated
* No bilateral Wilms' tumors (stage IV)

* Patients should be referred to COG-AREN0534
* Previously enrolled in clinical trial COG-AREN03B2
* Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
* Bilirubin ≤ 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
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
* No concurrent aprepitant

Disease(s) and\or Condition(s)

Stage III Kidney Wilms Tumor

Stage IV Kidney Wilms Tumor

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: RADIATION
- Name: 3-Dimensional Conformal Radiation Therapy
- Description:
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: PROCEDURE
- Name: Conventional Surgery
- Description:
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: DRUG
- Name: Cyclophosphamide
- Description: Given IV
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: BIOLOGICAL
- Name: Dactinomycin
- Description: Given IV
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: DRUG
- Name: Doxorubicin Hydrochloride
- Description: Given IV
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: DRUG
- Name: Etoposide
- Description: Given IV
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)
- Type: DRUG
- Name: Vincristine Sulfate Liposome
- Description: Given IV
- Arm Group Labels: Treatment (chemotherapy, surgery, radiotherapy)

Sponsor

Children's Oncology Group