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

September 11, 2020 updated by: Enmin Wang, Huashan Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Radiation
Intensity-modulated radiotherapy 20Gy/10fx
Device: Radiation
Hypofractionated Stereotactic Radiotherapy 30Gy/5fx
Drug: Temozolomide
Temozolomide 75 mg/m2 concurrently administered with RT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From the start of treatment to the date of death or the last follow-up, up to approximately 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
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
Progression-free survival (PFS)
Time Frame: From the start of treatment to the date of disease progression or death, up to approximately 24 months
Estimated using the Kaplan-Meier method
From the start of treatment to the date of disease progression or death, up to approximately 24 months
Objective response rate (ORR)
Time Frame: Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months
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
Toxicity rate
Time Frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
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
Quality of Life score (QoL)
Time Frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Enmin Wang, MD, CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2020-791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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