Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Brief 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. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk).

SECONDARY OBJECTIVES:

I. Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker.

II. Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only.

III. Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse.

IV. Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk).

STRATUM I: (very low-risk disease) Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metac
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Event Free Survival Probability [ Time Frame: 4 years ]
    Probability of no relapse, secondary malignancy, or death after 4 year in the study.
  • Overall Survival (OS) Probability [ Time Frame: 4 years ]
    Probability of being alive after 4 years in the study.


Original Primary Outcome:

Current Secondary Outcome:

  • Incidence of Contralateral Kidney Lesions [ Time Frame: During follow-up ]
    Number of contralateral kidney lesions during follow-up.
  • Incidence of Renal Failure [ Time Frame: During follow-up ]
    Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: July 13, 2006
Date Started: October 2006
Date Completion:
Last Updated: April 5, 2017
Last Verified: May 2016