CTRI/2013/10/004076已完成2 期
An Open Label, Prospective, Multicentric Study to Evaluate the Safety and Efficacy of BIOMAb-EGFRTM (Nimotuzumab) As Induction and Maintenance Therapy in Combination with Radiotherapy plus Temozolomide (Concomitant and Adjuvant) In Indian Patients with Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
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
入选标准
- •Willingness by the Patient or Legally acceptable representative (LAR) to sign the informed consent
- •Newly diagnosed patients with GBM (Grade 4 Astrocytoma) confirmed by histopathology
- •Patients suitable for planned radiotherapy and chemotherapy with TMZ
- •Patients who are chemotherapy naive
- •Patients aged between 18 - 70 years (both inclusive)
- •Karnofskyâ??s Performance Status >= 60%
- •Adequate hematological, renal & hepatic function defined as:
- •Hb ï?³ 9g/dL, ANC ï?³ 1500/mm3 & Platelet count ï?³ 100,000 /mm3
- •Serum creatinine <= 1.5 times ULN for laboratory
- •LFT < 3 times ULN for laboratory
- •Patients who have undergone debulking surgery or tumor biopsy in the last 4 weeks are eligible for enrollment
- •Patients should be willing to use effective methods of contraception during the study
排除标准
- •Female patients who are pregnant or breast feeding
- •Patients with severe underlying disease or not controlled by treatment in the opinion of the principal investigator
- •HIV, Chronic Hepatitis B or C if found to be positive
- •Hypersensitivity to TMZ and BIOMAb-EGFRTM (Nimotuzumab) or any of its components
- •Previous or concurrent malignancies in other sites except surgically cured carcinoma-in-situ of cervix & non melanoma skin cancer
研究者
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