HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM (HSCK-010)

Fudan University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Glioma, Malignant

Treatments: Drug: Temozolomide; Device: Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04547621

KY2020-791

Details and patient eligibility

About

This study aims to evaluate the safety and effectiveness of the combination of 30Gy/5fx HSRT and 20Gy/10fx IMRT adjuvant therapy. The total biological effective dose (BED) of the PTV is 72 Gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60Gy/30fx treatment. This study can provide evidence for future non-inferiority phase III randomized controlled trials. The abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-70 years of age;
2. Karnofsky performance status (KPS) ≥ 60 within 14 days prior to registration;
3. Histopathologically proved diagnosis glioblastoma multiforme;
4. Underwent surgery, gross total resection or subtotal resection;
5. Estimated survival of at least 3 months;
6. Hgb > 90/gL; absolute neutrophil count (ANC) > 1.5×109/L, platelets > 80×109/L; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;
7. Signed informed consent form;
8. Agreed to participate in the follow-up.

Exclusion criteria

1. Prior invasive malignancy unless disease free;
2. Received irradiation or other anti-tumor adjuvant therapies;
3. Brain stem disease or tumor greater than 6 cm in maximum diameter;
4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
5. Pregnancy or nursing mothers;
6. Participated in other trials after diagnosis;
7. Influence factors toward oral medications;
8. Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration;
9. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
10. Long-term unhealed wounds or fractures;
11. History of organ transplantation;
12. Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HSRT+IMRT+Temozolomide

Experimental group

Description:

* Intensity-modulated radiotherapy 20Gy/10fx, 5 days a week for 2 weeks. * Hypofractionated stereotactic radiotherapy 30Gy/5fx, 5 days a week for 1 week. * Temozolomide once daily (75mg/m2/d) orally administered concurrently with radiotherapy.

Treatment:

Drug: Temozolomide

Device: Radiation

Device: Radiation