Clinical Trial: Chemotherapy Before and After Surgery in Treating Children With Wilm's Tumor

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

Official Title: Nephroblastoma (Wilms Tumour) Clinical Trial And Study

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery. Giving more chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilm's tumor.

PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilm's tumor.


Detailed Summary:

OBJECTIVES:

  • Determine the response rate in children with Wilms' tumor treated with pre-operative chemotherapy.
  • Compare the response rate in children with intermediate-risk stage II or III Wilms' tumor treated with or without doxorubicin after surgery.
  • Determine the prognostic significance of histological subtypes in these patients after pre-operative chemotherapy.
  • Determine whether reduced treatment minimizes acute and late toxicity without jeopardizing event-free and overall survival in patients with focal anaplasia or intermediate-risk stage I Wilms' tumor.
  • Determine the prognostic significance of tumor volume and specimen weight after pre-operative chemotherapy and its relation to histological subtype in these patients.
  • Determine the effect of single-dose dactinomycin as pre-operative chemotherapy in these patients.
  • Correlate allele loss at 16q, 1p, and other chromosomal regions with relapse-free and overall survival of patients treated with these regimens.
  • Correlate allele losses with clinical risk factors (e.g., histological appearance and tumor volume) after pre-operative chemotherapy in these patients.
  • Determine laboratory indicators of myocardial damage in patients treated with these regimens.
  • Determine the prognostic significance of the percentage of necrosis after pre-operative chemotherapy, in terms of type and amount of residual viable tumor, in these patients.

OUTLINE: This is a partially randomized, multicenter study. Patients are stratified according to country
Sponsor: University of Leicester

Current Primary Outcome:

  • Event-free survival
  • Treatment failure, in terms of disease recurrence or death


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 3, 2002
Date Started: January 2001
Date Completion:
Last Updated: June 23, 2014
Last Verified: June 2009