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HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM (HSCK-010)

Primary Purpose

Glioma, Malignant

Status

Active

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Radiation

Temozolomide

About this trial

This is an interventional treatment trial for Glioma, Malignant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-70 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.

Exclusion Criteria:

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.

Sites / Locations

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HSRT+IMRT+Temozolomide

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival (OS)

Estimated using the Kaplan-Meier method

Secondary Outcome Measures

Progression-free survival (PFS)

Estimated using the Kaplan-Meier method

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.

Quality of Life score (QoL)

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0

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.

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.

Full Information

NCT ID

NCT04547621

First Posted

September 7, 2020

Last Updated

September 11, 2020

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04547621

Brief Title

HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HSRT+IMRT+Temozolomide

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Radiation

Intervention Description

Intensity-modulated radiotherapy 20Gy/10fx

Intervention Type

Device

Intervention Name(s)

Radiation

Intervention Description

Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Temozolomide 75 mg/m2 concurrently administered with RT.

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

Estimated using the Kaplan-Meier method

Time Frame

From the start of treatment to the date of death or the last follow-up, up to approximately 24 months

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Estimated using the Kaplan-Meier method

Time Frame

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

Title

Objective response rate (ORR)

Description

Time Frame

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

Title

Quality of Life score (QoL)

Description

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0

Time Frame

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

Title

Cognitive function

Description

Time Frame

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

Title

Toxicity rate

Description

Common Terminology Criteria for Adverse Events (CTCAE) 5.0 to assess the toxicity. Estimated using an exact binomial distribution together with 95% confidence interval.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-70 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enmin Wang, MD

Organizational Affiliation

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

15758009

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. doi: 10.1056/NEJMoa043330.

Results Reference

background

PubMed Identifier

24895599

Citation

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.

Results Reference

background

PubMed Identifier

26392096

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.

Results Reference

background

PubMed Identifier

35906549

Citation

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.

Results Reference

derived

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HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

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