Hypofractionated radiotherapy for glioblastoma treatment

A Randomized, Open, Controlled, Multi-center Clinical Trial of Hypofractionated Postoperative Radiotherapy for Adult Glioblastoma

This study is testing a new way of giving radiation therapy combined with a medication for people with newly diagnosed glioblastoma to see if it helps them live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: bevacizumab, radiation, chemotherapy
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06740955 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide in patients with newly diagnosed glioblastoma. A total of 420 subjects are enrolled and randomized into two groups to compare different radiation doses after surgery. The study considers factors such as the extent of surgical resection and MGMT promoter methylation expression to assess overall survival time. Participants undergo a screening period to determine eligibility before randomization.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed glioblastoma who have undergone complete or partial tumor resection.

Not a fit: Patients with conditions that prevent them from undergoing surgery or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve overall survival rates for patients with glioblastoma.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Newly diagnosed glioblastoma confirmed by histopathology or molecular pathology;
2. Complete or partial tumor resection or biopsy via neurosurgery;
3. The age of signing the informed consent form was 18-70 years old, male or female; (4) KPS score ≥60; (5) expected survival time ≥6 months;

6\. Radiotherapy should be started within 6 weeks after surgery; 7. Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : Normal bone marrow reserve: white blood cell (WBC) ≥3.0×109/L, neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (Hb) ≥90 g/L Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 ml/ minute (Cockcroft-Gault equation) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN); 8. Able and willing to follow the study and follow-up procedures; 9. Men and women of childbearing potential must agree to use adequate contraception throughout the study and for 6 months after the end of treatment. Female subjects of childbearing potential were required to have a negative blood pregnancy test within 72 hours before the first dose.

10\. The subjects voluntarily participated in this clinical study and signed the informed consent form. The compliance was good and the subjects could cooperate with the follow-up.

Exclusion Criteria:

1. Received any previous systemic antitumor therapy against the target lesion;
2. Prior radiation therapy to the head;
3. Had a history of low-grade glioma and the current tumor transitioned to glioblastoma;
4. The patient had glioma in other parts in the past, and now had metastasis, and the metastatic site was glioblastoma.
5. Subjects were unable to undergo MRI examination or unable to undergo enhanced MRI examination.
6. Patients who received bevacizumab or iodine internal radiation within one month before enrollment;
7. Participants who participated in other clinical trials within 1 month before enrollment;
8. Subjects with severe trauma or severe infection within 1 month before enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.
9. Severe cardiovascular disease: grade Ⅱ or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade ⅲ-ⅳ cardiac dysfunction (according to the New York Heart Association NYHA classification, see Appendix 3) or left ventricular ejection fraction (LVEF) less than 50% on echocardiography;
10. Subjects underwent major surgery (excluding glioma surgery) within 4 weeks before enrollment;
11. The subjects had a history of psychotropic drug abuse or drug use;
12. Patients with other malignant tumors within 5 years before enrollment (if cured) were excluded;
13. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA≥500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and C;
14. Subjects were allergic to temozolomide or could not receive temozolomide treatment for other reasons;
15. The results of blood pregnancy test of female subjects during non-lactation period and within 7 days before the first study treatment were positive. The subject (male or female) declined to commit to using at least one acceptable contraceptive method (i.e., using an intrauterine device (IUD), condom, any form of hormonal contraceptive, or abstinence, etc.) for the entire duration of the study and for 3 months after the last study treatment;
16. Other conditions that increase the risk associated with participating in the study or the study drug and, in the investigator's judgment, may make the subject ineligible for the study;
17. The investigator determined that he was not fit to participate in the study.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: 硙岩 石

Conditions Glioblastoma