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临床试验/NCT07368283
NCT07368283尚未招募不适用

A Single-arm Phase II Non-inferiority Clinical Study of Limited Target Volume Radiotherapy After Glioblastoma Surgery

Jiangxi Provincial Cancer Hospital0 个研究点目标入组 79 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
79
主要终点
6m PFS

研究概览

简要总结

Research on radiotherapy target volumes for glioblastoma is increasingly focused on exploring more limited yet effective irradiation fields, aiming to achieve local control while minimizing acute and long-term neurotoxicity. Previous retrospective analysis by investigators revealed that local recurrences of glioblastoma are predominantly confined to a narrow margin around the original lesion: 98.3% of recurrences occurred within 0.5 cm of the original T2-FLAIR abnormality, 94.8% within 1 cm of the original T1-enhanced region. These findings have been cited in the ESTRO-EANO treatment guidelines. Building on this evidence, investigators plan to conduct a single-arm, phase II clinical trial to systematically evaluate the efficacy and safety of a 1 cm radiotherapy target volume in post-operative glioblastoma patients.Eligible patients with glioblastoma who have undergone surgical resection will be selected to receive limited-field radiotherapy. The target volume will be defined based on the postoperative MRI enhancing lesion: a 1 cm margin will be added to form the clinical target volume (CTV), followed by a further 0.3 cm margin to create the planning target volume (PTV). A total dose of 60 Gy will be delivered in 30 fractions (2 Gy per fraction, 5 fractions per week). Concurrent and adjuvant chemotherapy will be administered per standard guidelines. The primary efficacy endpoints are the 6-month progression-free survival rate and the incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher. Secondary endpoints include overall survival, patterns of recurrence, neurocognitive function, and quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 70 years.
  • Diagnosed with glioblastoma by surgical pathology, with the extent of resection achieving maximal safe resection.
  • Within 2 to 6 weeks after surgery
  • In good physical condition with a Karnofsky Performance Status (KPS) score ≥
  • Hematological, hepatic, and renal functions are essentially normal.
  • Signed informed consent, willing to undergo treatment and follow-up as stipulated in the study protocol.

排除标准

  • Prior history of cranial radiotherapy or other malignant tumors.
  • Severe dysfunction of vital organs (e.g., heart, liver, kidneys) that precludes tolerance to radiotherapy.
  • Active infection, immune system disorders, or other serious chronic diseases.
  • Pregnancy or lactation.
  • Psychiatric disorders or severe cognitive impairment that compromises the ability to cooperate with treatment and follow-up.

研究组 & 干预措施

limited-field radiotherapy Group

Other

干预措施: limited-field radiotherapy (Radiation)

结局指标

主要结局

6m PFS

时间窗: up to 6 month

6-month progression-free survival rate

incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher

时间窗: Up to 24 months

次要结局

  • OS(Up to 24 months)
  • Location of first recurrence relative to radiation field (in-field, marginal, or distant)(Up to 24 months)
  • Cognitive function assessed by Mini-Mental State Examination (MMSE) score(Up to 24 months)
  • Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score(Up to 24 months.)
  • Health-Related Quality of Life as assessed by the EORTC QLQ-C30 Global Health Status / QoL scale(Up to 24 months)
  • Disease-Specific Quality of Life as assessed by the EORTC QLQ-BN20 summary score(Up to 24 months)
  • Quality of Life as assessed by the FACT-Br Total Score(Up to 24 months)

研究者

发起方
Jiangxi Provincial Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiping Chen

Director of the Head and Neck Radiation Therapy Department,Jiangxi cancer Hospital

Jiangxi Provincial Cancer Hospital

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