NCT05433402撤回1 期
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.
Sadat City University1 个研究点 分布在 1 个国家开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
chlorpromazine displays a series of remarkable bio-molecular effects in cancer cells, as inhibition of cell growth, nuclear aberrations, inhibition of the phosphoinositide 3-kinase/mammilian target of rapamycin (PI3K/mTOR) axis, induction of cytotoxic autophagy, inhibition of glutamate and DRD2 receptors. This study will evaluate the addition of chlorpromazine to the first-line therapeutic protocol in colon cancer stage III.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥18 years old.
- •Patients with histologically confirmed surgically resected stage III colon cancer
- •No rectal cancer
- •Stage III disease (any pT, N1-2, M0)
- •Patients should have a good performance status according to Eastern Cooperative Oncology Group (ECOG) score (ECOG 0-2).
- •Patients with normal organic function as defined for the following criteria:
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL);
- •Total serum bilirubin ≤ 2.0 x ULN-LL;
- •Absolute neutrophil count ≥ 1,500 / mm3;
- •Platelet count ≥ 100,000 / mm3;
- •Hemoglobin ≥ 8.0 g / dl;
- •Serum creatinine ≤ 1.5 x ULN-LL
- •Patients should undergone curative-intent complete surgical resection
- •Patients have at least one month from any major surgery to start of intervention
- •Written informed consent before enrollment
排除标准
- •Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)
- •Patients with metastatic disease
- •Patients who scheduled to receive any form of further adjuvant cancer therapy (A malignancy currently under active therapy
- •Pregnant or breast-feeding patients
- •Patients with known hypersensitivity or intolerance to CPZ
- •Patients with serious illness or psychiatric condition.
- •Patients have current participation in other protocols with experimental drugs.
- •Patients with no ability to ingest food orally.
- •Patients who have familial adenomatous polyposis, hereditary non-polyposis rectal cancer, or inflammatory bowel disease
- •Patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
研究组 & 干预措施
Control
Active Comparator
干预措施: Control (Drug)
Chloropromazine
Experimental
干预措施: ChlorproMAZINE 50 MG (Drug)
结局指标
主要结局
Disease-free survival
时间窗: one year
Disease-free survival as measured by Logrank
次要结局
- Overall survival(one year)
- Time occurrence of new primary colon cancer and new polyps(one year)
研究者
Mahmoud Samy Abdallah
Principle Investigator
Sadat City University
研究点 (1)
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