CTRI/2024/09/073887招募中不适用
Assessing the Need for Rescue Granulocyte Colony Stimulating Factor (GCSF) in patients receiving primary prophylaxis with Peg GCSF post Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Incidence of Febrile Neutropenia
研究概览
简要总结
The phenomenon of primary PEG G-CSF failure and the subsequent utilization of rescue G-CSF represent areas of inquiry that have received limited exploration, despite being encountered frequently by physicians. Our study aims to elucidate the practical application of rescue G-CSF following primary Peg G-CSF failure, as well as to ascertain the incidence of febrile neutropenia in our clinical setting and document the complications associated with the use of rescue G-CSF.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients more than 18 years of age
- •Patients with a histopathological proven diagnosis of cancer for whom first-line chemotherapy is being planned
- •High-risk or Intermediate-risk patients with more than or equal to 1 high-risk feature, requiring PEGylated G-CSF as a part of their chemotherapeutic regime.
排除标准
- •Patients who are on treatment and have previously received chemotherapy or radiation in the past or present.
- •Leukemias (Acute lymphoid leukaemia, acute myeloid leukaemia, and chronic lymphoid leukaemia) will be excluded.
结局指标
主要结局
Incidence of Febrile Neutropenia
时间窗: 12 weeks
次要结局
- PEG GCSF toxicity(12 weeks)
- Outcome at first response assessment(6 months)
研究者
Asif Rahman K A
Amala Institute of Medical Sciences
研究点 (1)
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