Chemotherapy + Radiation for Kidney Cancer (Wilms' Tumor)

Recruiting in Palo Alto (17 mi)

+319 other locations

Overseen byDavid B Dix

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

David B Dix

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients with a new diagnosis of stage III or IV Wilms' tumor. They must start treatment within two weeks after surgery or biopsy, have acceptable liver function and heart performance, and not be pregnant or breastfeeding. Those who've had prior tumor treatments (except in specific circumstances) can't join.

Inclusion Criteria

Fertile patients must use effective contraception

I can perform most of my daily activities without assistance.

Not pregnant or nursing

See 10 more

Treatment Details

Interventions

3-dimensional Conformal Radiation Therapy (Radiation)
Cyclophosphamide (Alkylating agents)
Dactinomycin (Anti-tumor antibiotic)
Doxorubicin Hydrochloride (Topoisomerase II inhibitors)
Etoposide (Topoisomerase II inhibitors)
Liposomal Vincristine Sulfate (Vinca alkaloids)

Trial OverviewThe study is examining the effectiveness of combination chemotherapy with drugs like Doxorubicin Hydrochloride and Vincristine Sulfate Liposome, either alone or combined with radiation therapy, to see if this approach better kills cancer cells in children with advanced kidney tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, surgery, radiotherapy)Experimental Treatment7 Interventions

REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy. Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M. REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.

Cyclophosphamide is already approved in Canada, Japan for the following indications: