NCT07368283Not yet recruiting
Limited Target Volume Radiotherapy After Glioblastoma Surgery
A Single-arm Phase II Non-inferiority Clinical Study of Limited Target Volume Radiotherapy After Glioblastoma Surgery
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 79 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT07368283
What you commit to
- Study type: Interventional
- Planned participants: 79
- From 1 Jan 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of cranial radiotherapy or other malignant tumors.
Other illness
- 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.
- Psychiatric disorders or severe cognitive impairment that compromises the ability to cooperate with treatment and follow-up.
Other
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.