HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

NCT04547621 | Unknown Phase 1 FDA Drug FDA Device

• 1 other identifier: KY2020-791
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-free survival (PFS)

  From the start of treatment to the date of disease progression or death, up to approximately 24 months

• Objective response rate (ORR)

  Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months

• Quality of Life score (QoL)

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

• Cognitive function

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

• Toxicity rate

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

Study Arms (1)

HSRT+IMRT+Temozolomide

EXPERIMENTAL

* 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.

Device: Radiation; Drug: Temozolomide

Interventions

Radiation DEVICE

Intensity-modulated radiotherapy 20Gy/10fx

HSRT+IMRT+Temozolomide

Temozolomide DRUG

Temozolomide 75 mg/m2 concurrently administered with RT.

HSRT+IMRT+Temozolomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• Karnofsky performance status (KPS) ≥ 60 within 14 days prior to registration;
• Histopathologically proved diagnosis glioblastoma multiforme;
• Underwent surgery, gross total resection or subtotal resection;
• Estimated survival of at least 3 months;
• 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;
• Signed informed consent form;
• Agreed to participate in the follow-up.

You may not qualify if:

• Prior invasive malignancy unless disease free;
• Received irradiation or other anti-tumor adjuvant therapies;
• Brain stem disease or tumor greater than 6 cm in maximum diameter;
• Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
• Pregnancy or nursing mothers;
• Participated in other trials after diagnosis;
• Influence factors toward oral medications;
• Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration;
• 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%;
• Long-term unhealed wounds or fractures;
• History of organ transplantation;
• Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (4)

• 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.

  PMID: 15758009 BACKGROUND

• 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.

  PMID: 24895599 BACKGROUND

• 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.

  PMID: 26392096 BACKGROUND

• 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.

  PMID: 35906549 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Enmin Wang, MD

  CyberKnife Center, Department of Neurosurgery, Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

CN (1)