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临床试验/NCT00626730
NCT00626730Unknown2 期

Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study

European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
2 期
入组人数
78
试验地点
2
主要终点
Progression-free survival

研究概览

简要总结

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma.

详细描述

OBJECTIVES:

Primary

  • To assess the impact of high-dose radiotherapy (RT) on progression-free survival (PFS), treatment tolerance, and post-treatment global cognitive functioning in patients with atypical (WHO grade II) or malignant ( WHO grade III) meningioma.

OUTLINE: Patients with grade II disease are stratified according to resection status (complete excision [Simpson's stages 1-3] vs incomplete excision [Simpson's stages 4-5]) and participate in a phase II study. These patients are assigned to 1 of 2 treatment groups according to Simpson staging. Only data from these patients is analyzed with respect to the progression-free survival endpoint. Patients with grade III disease are treated in group 1 or 2 according to Simpson staging (as patients with grade II disease). After treatment, the clinical results from these patients are observed and described.

  • Group 1 (Simpson stage 1-3): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 6 weeks.
  • Group 2 (Simpson stage 4-5): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 7 weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
主要目的
Treatment

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Progression-free survival

次要结局

  • Adverse events as assessed by NCI CTCAE v3.0
  • Overall survival
  • Mini-mental status exam

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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