HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

NCT ID: NCT04547621

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-01-01

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.

Conditions

Glioma, Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiation

Intervention Type: DEVICE

Intensity-modulated radiotherapy 20Gy/10fx

Radiation

Intervention Type: DEVICE

Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

Temozolomide

Intervention Type: DRUG

Temozolomide 75 mg/m2 concurrently administered with RT.

Interventions

Radiation

Intensity-modulated radiotherapy 20Gy/10fx

Intervention Type: DEVICE

Radiation

Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

Intervention Type: DEVICE

Temozolomide

Temozolomide 75 mg/m2 concurrently administered with RT.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Enmin Wang

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enmin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Locations

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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. doi: 10.1056/NEJMoa043330.

Reference Type: BACKGROUND

PMID: 15758009 (View on PubMed)

Martinez-Carrillo M, Tovar-Martin I, Zurita-Herrera M, Del Moral-Avila R, Guerrero-Tejada R, Saura-Rojas E, Osorio-Ceballos JL, Arrebola-Moreno JP, Exposito-Hernandez 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.

Reference Type: BACKGROUND

PMID: 24895599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26392096 (View on PubMed)

Guan Y, Pan M, Yang J, Lu Q, Han L, Liu Y, Li J, Zhu H, Gong X, Mei G, Liu X, Pan L, Dai J, Wang Y, Wang E, Wang X. A phase II open label, single arm study of hypofractionated stereotactic radiotherapy with chemoradiotherapy using intensity-modulated radiotherapy for newly diagnosed glioblastoma after surgery: the HSCK-010 trial protocol. BMC Cancer. 2022 Jul 29;22(1):827. doi: 10.1186/s12885-022-09914-5.

Reference Type: DERIVED

PMID: 35906549 (View on PubMed)

Other Identifiers

KY2020-791

Identifier Type: -

Identifier Source: org_study_id