drugset / Trial / NCT00335556

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

NCT00335556 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Timeline

Start
2006-06
Primary completion
2015-12
Completion
—

Outcome

Mixed primary results

registry NUMBER UH-1: 76.1 (62.5 to 89.6) Percentage of 4-year OS NCT00335556 ↗

registry NUMBER Window/UH-1: 25.0 (0 to 67.4) Percentage of 4-year OS NCT00335556 ↗

registry analysis (other test); UH-1 vs Window/UH-1 vs UH-2; p = .0199; Log Rank Test Statistic 5.4190; Log Rank NCT00335556 ↗

registry analysis (other test); UH-1; p = .3478; Log Rank Test Statistic .8814; Log Rank NCT00335556 ↗

registry analysis (other test); Regimen DD-4A; p = .0570; Log Rank Test Statistic 3.6216; Log Rank NCT00335556 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Dactinomycin Unknown — Intravenous
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Irinotecan Small molecule — Intravenous
Subject Vincristine Small molecule — Intravenous