Clinical Trial: Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Brief Summary: This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Bilateral Wilms tumor and children who are a special risk for forming tumors in both kidneys. 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Detailed Summary:

OBJECTIVES:

I. To improve 4-year event-free survival (EFS) to 73% for young patients with bilateral Wilms tumor (BWT).

II. To prevent complete removal of at least one kidney in 50% of patients with BWT by using prenephrectomy 3-drug chemotherapy induction with vincristine (vincristine sulfate), dactinomycin, and doxorubicin (doxorubicin hydrochloride).

III. To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.

IV. To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.

V. To have 75% of patients with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy.

OUTLINE:

PREOPERATIVE CHEMOTHERAPY: Patients receive preoperative chemotherapy according to radiographic stage.

VAD REGIMEN (stage I-IV bilateral Wilms tumor [BWT] with biopsy revealing favorable histology or no preoperative biopsy; stage I-III BWT with focal anaplasia; stage I BWT with diffuse anaplasia; or high-risk, stage III-IV unilateral Wilms tumor [WT] with contralateral nephrogenic rest [NR] or predisposition syndrome): Patients receive vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, 22, 29, and 36 (weeks 1-6) and dactinomycin IV and doxorubicin hydrochloride IV ove
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Event-free survival [ Time Frame: 4 years ]
  • Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT) [ Time Frame: Up to 12 weeks ]
  • Efficacy of chemotherapy in preserving renal units and preventing Wilms tumor development in patients with diffuse hyperplastic perilobular nephrogenic rests [ Time Frame: Up to 10 years ]
  • Facilitation of partial nephrectomy in lieu of total nephrectomy in 25% of patients with unilateral Wilms tumor [ Time Frame: Up to 12 weeks ]
  • Percentage of patients with bilateral Wilms tumor (BWT) undergoing definitive surgical treatment by week 12 [ Time Frame: 12 weeks ]


Original Primary Outcome:

  • 4-year event-free survival
  • Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT)
  • Efficacy of chemotherapy in preserving renal units and preventing Wilms tumor development in patients with diffuse hyperplastic perilobular nephrogenic rests
  • Facilitation of partial nephrectomy in lieu of total nephrectomy in 25% of patients with unilateral Wilms tumor
  • Percentage of patients with BWT undergoing definitive surgical treatment by week 12


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: July 22, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 28, 2016
Last Verified: November 2016