Study on Chemotherapy With or Without Radiation for Young Patients With Newly Diagnosed Advanced Wilms' Tumor

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00379340

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This clinical trial is exploring how well chemotherapy, with or without radiation therapy, works in treating young patients with newly diagnosed advanced Wilms' tumor, a type of kidney cancer. The study aims to find the best treatment approach to stop the growth of cancer cells.

Patient Parameters

Program Overview

This study is testing whether a combination of chemotherapy drugs, with or without radiation therapy, can effectively treat young patients with newly diagnosed stage III or stage IV Wilms' tumor. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy x-rays to target and kill cancer cells. The goal is to see if using multiple drugs together, with or without radiation, can improve treatment outcomes.

Description

The main goals of this study are to see how well young patients with stage IV Wilms' tumor, which has spread to the lungs, respond to chemotherapy without needing whole lung radiation. The study also looks at patients who do not respond fully to initial treatment and need additional drugs. Another focus is on patients with stage III or IV Wilms' tumor with specific genetic changes, to see how they respond to a different chemotherapy regimen.

The study involves multiple centers and follows specific treatment plans:

  • Regimen DD4A (weeks 1-6): Patients receive a combination of chemotherapy drugs, including dactinomycin, vincristine, and doxorubicin. If the cancer has spread to the lungs or other areas, radiation therapy may be given.

  • Regimen DD4A (weeks 7-25): Patients who respond well to initial treatment continue with the same chemotherapy drugs over several weeks.

  • Regimen M (weeks 7-31): Patients who do not respond fully to initial treatment or have specific genetic changes receive additional chemotherapy drugs, cyclophosphamide and etoposide, along with the original drugs. Radiation therapy may also be given if needed.

Patients are monitored throughout the treatment and for 10 years after to track their progress and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with Wilms' tumor, meeting one of the following:
    • Stage IV disease with favorable histology, with or without specific genetic changes.
    • Stage III disease with favorable histology and specific genetic changes, transferring from another clinical trial.
  • Must start treatment within 14 days after surgery or biopsy, unless medically unable.
  • No bilateral Wilms' tumors (stage IV).
  • Previously enrolled in a related clinical trial.
  • Good overall health, with specific performance status scores.
  • Normal liver function tests and heart function.
  • Not pregnant or nursing, with a negative pregnancy test.
  • Must use effective birth control if fertile.
  • No prior chemotherapy or radiation for the tumor, unless transferring from another trial or for urgent medical reasons.
  • No use of the medication aprepitant.

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