Health TrialsbyHealthPanel

Limited Target Volume Radiotherapy After Glioblastoma Surgery

ConditionGlioblastoma (GBM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangxi Provincial Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • limited-field radiotherapy

    Radiation

    limited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy

Treatment groups

79 Participants
are divided into 1 treatment group
Group A: limited-field radiotherapy GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

6m PFS

6-month progression-free survival rate

Time frame
up to 6 month
2

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

Time frame
Up to 24 months

Secondary outcomes

1

OS

overall survival

Time frame
Up to 24 months
2

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
3

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
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangxi Provincial Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: