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临床试验/JPRN-jRCTs042220014
JPRN-jRCTs042220014招募中2 期

eoadjuvant fractionated stereotactic radiotherapy followed by surgical resection for brain metastases: efficacy and safety study

Mitsuya Koichi0 个研究点目标入组 57 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
57

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 <= 79age old(—)
性别
All

入选标准

  • 1. Distinct number of brain metastases <= 4, One with surgical indication
  • 2. Index lesion should be >= 2 cm and <= 5 cm in largest dimension, and require resection. Index lesions will be treated with SRS and surgery.
  • 3. All of index lesion exist cerebrum or cerebellar.
  • 4. No radiographic evidence of leptomeningeal disease
  • 5. Eastern Cooperative Oncology Group performance status (ECOG-PS) scores of 0 to 2 and 3 if a result of only neurologic symptoms caused by the tumor.
  • 6. Primary tumors were non-small-cell lung cancer as well as cancers of the breast, colon, kidney, ovary, uterine cervix and corpus, stomach, or esophagus.
  • 7. Primary cancer and/or extra cranial metastases is not progressive critically.
  • 8. Age 20 to 79 years.
  • 9. Patients who have received prior whole brain radiotherapy and/or craniotomy.
  • 10. WBC >= 2,000 /mm3, Hb >= 8.0 g/dl, PLT >=10x104 /mm3, AST <= 120 IU/l, ALT <= 120 IU/l,
  • CRE <= 1.5 mg/dl
  • 11. All patients provided written informed consent.

排除标准

  • Documented history of active other malignancy
  • Pregnant, breastfeeding, or woman of childbearing
  • age without effective contraception
  • Patient with psychiatric disorder
  • Contraindication to gadolinium injection
  • Emergent surgery needed condition (impending cerebral herniation or acute hydrocephalus)

研究者

发起方
Mitsuya Koichi

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