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临床试验/NCT06340243
NCT06340243尚未招募不适用

Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt

Assiut University0 个研究点目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enas Saad Hassan

principle investigator

Assiut University

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