Intergroup Protocol for Treatment of Children With Hepatoblastoma

Children's Oncology Group1 个研究点分布在 1 个国家目标入组 277 人开始时间: 1999年3月最近更新: 2013年6月14日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Children's Oncology Group
入组人数: 277
试验地点: 1
主要终点: Event-free survival (EFS) rates

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer. This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.

详细描述

PRIMARY OBJECTIVES:

I. To estimate the response and efficacy of amifostine (amifostine trihydrate) in reducing the toxicity associated with platinum agents.

II. To test whether there is any effect of amifostine on event-free survival by comparing outcome of those treated with amifostine to those treated without on this study and with historic controls.

SECONDARY OBJECTIVES:

I. To estimate the event-free survival of patients with stage I pure fetal histology treated with surgery alone.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 21 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically proven hepatoblastoma
•Any stage allowed(stages II-IV closed to accrual as of 11-25-03)
•Stratum 1 (stage I):
•Pure fetal histology
•Complete surgical resection of tumor
•Stratum 2 (stages I or II) (stage II closed to accrual as of 11-25-03), meeting 1 of the following criteria:
•Complete resection of tumor with histology other than pure fetal
•Gross resection of tumor, including resected tumors with preoperative/intraoperative rupture
•Stratum 3 (stages III or IV) (stages III and IV closed to accrual as of 11-25-03), meeting 1 of the following criteria:
•Unresectable tumors
•Partial resection of tumor with measurable residual disease OR lymph node involvement
•Measurable metastatic disease to lungs or other organs
•No hepatocellular carcinoma
•Creatinine normal for age
•Glomerular filtration rate normal for age
•Not pregnant or nursing
•Fertile patients must use effective contraception
•No prior biologic therapy
•No prior chemotherapy
•No prior endocrine therapy
•No prior radiotherapy
•See Disease Characteristics
•No prior therapy except tumor resection

排除标准

未提供

研究组 & 干预措施

Arm I (cisplatin, vincristine sulfate, fluorouracil)

Experimental

Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.

干预措施: therapeutic conventional surgery (Procedure)

Arm I (cisplatin, vincristine sulfate, fluorouracil)

Experimental

Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.

干预措施: cisplatin (Drug)

Arm I (cisplatin, vincristine sulfate, fluorouracil)

Experimental

Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.

干预措施: vincristine sulfate (Drug)

Arm I (cisplatin, vincristine sulfate, fluorouracil)

Experimental

Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.

干预措施: fluorouracil (Drug)