HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

Glioma, Malignant Clinical Trial

— HSCK-010  

Official title:

The Combination of Hypofractionated Stereotactic Radiotherapy and Chemoradiotherapy Using Intensity-Modulated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04547621
• Other study ID #: KY2020-791
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2020
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Intervention

Device:
• Radiation
Intensity-modulated radiotherapy 20Gy/10fx
• Radiation
Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

Drug:
• Temozolomide
Temozolomide 75 mg/m2 concurrently administered with RT.

Locations

Country	Name	City	State
China	CyberKnife Center, Department of Neurosurgery, Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Martínez-Carrillo M, Tovar-Martín I, Zurita-Herrera M, Del Moral-Ávila R, Guerrero-Tejada R, Saura-Rojas E, Osorio-Ceballos JL, Arrebola-Moreno JP, Expósito-Hernández J. Salvage radiosurgery for selected patients with recurrent malignant gliomas. Biomed Res Int. 2014;2014:657953. doi: 10.1155/2014/657953. Epub 2014 May 7. — View Citation

Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21. — View Citation

Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Estimated using the Kaplan-Meier method	From the start of treatment to the date of death or the last follow-up, up to approximately 24 months
Secondary	Progression-free survival (PFS)	Estimated using the Kaplan-Meier method	From the start of treatment to the date of disease progression or death, up to approximately 24 months
Secondary	Objective response rate (ORR)	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.	Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months
Secondary	Quality of Life score (QoL)	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Secondary	Cognitive function	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.	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Secondary	Toxicity rate	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 to assess the toxicity. Estimated using an exact binomial distribution together with 95% confidence interval.	Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months