Limited Target Volume Radiotherapy After Glioblastoma Surgery

N/ANot Yet RecruitingNCT07368283

Jiangxi Provincial Cancer Hospital79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 ≥ 60. * Hematological, hepatic, and renal functions are essentially normal. * Signed informed consent, willing to undergo treatment and follow-up as stipulated in the study protocol. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

6m PFS

6-month progression-free survival rate

Time frame: up to 6 month

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

Time frame: Up to 24 months

Secondary Outcomes

overall survival

Time frame: Up to 24 months

Location of first recurrence relative to radiation field (in-field, marginal, or distant)

The spatial relationship between the first documented site of disease recurrence/progression and the original radiation treatment plan will be determined by a core imaging laboratory. Recurrent lesions will be co-registered with the original planning CT/MRI and radiation dose distribution. Classification is based on the volume of the recurrent lesion covered by the 95% isodose line of the original prescription dose: In-field recurrence: \>80% of the recurrent lesion's volume is within the 95% isodose line. Marginal recurrence: 20% to 80% of the recurrent lesion's volume is within the 95% isodose line. Distant recurrence: \<20% of the recurrent lesion's volume is within the 95% isodose line. This classification criteria is adapted from the dosimetric analysis methods commonly used in radiotherapy studies (e.g., Patterns offailure for glioblastoma multiforme following limited-margin radiation and concurrent temozolomide. Radiation oncology 2014, 9:130.)

Time frame: Up to 24 months

Cognitive function assessed by Mini-Mental State Examination (MMSE) score

Cognitive function assessed by the Mini-Mental State Examination (MMSE). Scores range from 0 to 30, with higher scores indicating better cognitive function.

Time frame: Up to 24 months

Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score

Cognitive function assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.

Time frame: Up to 24 months.

Health-Related Quality of Life as assessed by the EORTC QLQ-C30 Global Health Status / QoL scale

Score on the Global Health Status / Quality of Life scale (Items 29 \& 30) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale range: 0-100. A higher score indicates a better overall quality of life.

Time frame: Up to 24 months

Disease-Specific Quality of Life as assessed by the EORTC QLQ-BN20 summary score

Summary score of the European Organization for Research and Treatment of Cancer Brain Cancer Module (EORTC QLQ-BN20). This scale assesses symptoms and issues specific to brain tumor patients (e.g., future uncertainty, visual disorder, motor dysfunction). Scale range and interpretation should be specified

Time frame: Up to 24 months

Quality of Life as assessed by the FACT-Br Total Score

Total score of the Functional Assessment of Cancer Therapy - Brain (FACT-Br). This questionnaire assesses physical, social, emotional, functional well-being, and additional concerns specific to brain tumor patients. Scale range: 0-200. A higher score indicates better quality of life.

Time frame: Up to 24 months

Limited Target Volume Radiotherapy After Glioblastoma Surgery

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts