HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

Phase 1

• Conditions: Glioma, Malignant
• Interventions: Device: Radiation; Drug: Temozolomide

• Registration Number: NCT04547621
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSRT+IMRT+Temozolomide	Radiation	* 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.
HSRT+IMRT+Temozolomide	Temozolomide	* 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.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	From the start of treatment to the date of death or the last follow-up, up to approximately 24 months	Estimated using the Kaplan-Meier method

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From the start of treatment to the date of disease progression or death, up to approximately 24 months	Estimated using the Kaplan-Meier method
Objective response rate (ORR)	Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months	ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Assessment in Neuro-Oncology (RANO) prior to progression or any further therapy.
Quality of Life score (QoL)	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
Cognitive function	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months	Mini-Mental State Exam (MMSE, score range 0 to 30) to evaluate the cognitive function. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Toxicity rate	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 to assess the toxicity. Estimated using an exact binomial distribution together with 95% confidence interval.

Trial Locations

Locations (1)

CyberKnife Center, Department of Neurosurgery, Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China