Limited Target Volume Radiotherapy After Glioblastoma Surgery

NCT07368283 | Not Yet Recruiting

• 1 other identifier: 2025ky249
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma (GBM)

Outcome Measures

Primary Outcomes (2)

• 6m PFS

  6-month progression-free survival rate

  up to 6 month

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

  Up to 24 months

Secondary Outcomes (7)

• 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

Study Arms (1)

limited-field radiotherapy Group

OTHER

Radiation: limited-field radiotherapy

Interventions

limited-field radiotherapy RADIATION

limited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy

limited-field radiotherapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Ziwei Tu

CONTACT

13755793552; tuziwei198803@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Head and Neck Radiation Therapy Department，Jiangxi cancer Hospital

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01