Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
研究概览
简要总结
determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome
详细描述
Hodgkin's lymphoma accounts for around 40% of all pediatric lymphomas and is the most prevalent cancer among adolescents and young adults. With combinations of chemotherapy and radiation, Hodgkin's lymphoma is roughly 80% curable, placing it among the most treatable cancers . Since the introduction of combination chemotherapy treatments 20 years ago, the prognosis for children with Hodgkin's lymphoma has improved. The treatment is mostly influenced by the stage of the disease at diagnosis, histology, existence of "B"-symptoms, and the presence of bulky disease. Nonetheless, 20% of patients do not achieve long-term remission, and around 20% experience treatment-related side effects such as secondary malignancies, infertility, cardiovascular disease, and organ malfunction following chemo-radiation .Studies of long-term therapy side effects were made possible by the significant number of survivors. The goal of therapy optimization protocols for pediatric patients with Hodgkin's lymphoma is to maintain excellent tumor control while limiting adverse effects and long-term consequences . It is critical to stratify patients based on reliable prognostic factors at presentation and according to the rapidity of response into low-risk (LR) patients who would benefit from less aggressive therapy, avoiding unnecessary toxic side effects, and high-risk (HR) patients who should be subjected to intensified therapy to reduce the rate of treatment failures and relapses .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma
排除标准
- •Patients aged more than 18 years old.
- •Patients who died early at presentation before starting chemotherapy
- •diagnosis of nodular lymphocytic predominant Hodgkin lymphoma
- •previous chemotherapy or radiotherapy other (simultaneous) malignancies
- •severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.
结局指标
主要结局
assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
时间窗: 2 years
determine if radiotherapy could be safely omitted for early responder patients without compromising outcome, it can be assessed by decrease in lymph node volume ,Volumes are approximated as ellipsoids. If a, b, c denote the principal axes of the ellipsoid the volume is calculated as V= (a x b x c)/2
次要结局
未报告次要终点
研究者
Enas Saad Hassan
principle investigator
Assiut University
