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HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04547621
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Huashan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Enmin Wang, MD
Principal Investigator Affiliation	CyberKnife Center, Department of Neurosurgery, Huashan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Malignant

Arms & Interventions

Arms

Experimental: HSRT+IMRT+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.

Interventions

Device: - Radiation

Intensity-modulated radiotherapy 20Gy/10fx

Device: - Radiation

Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

Drug: - Temozolomide

Temozolomide 75 mg/m2 concurrently administered with RT.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai, Shanghai, China

Status

Address

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai, 200040

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