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Glioma, MalignantPhase 1/2HSCK-010NCT04547621

HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

A Phase 1/2 study testing Radiation and Temozolomide in people with Glioma, Malignant, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioma, Malignant
What is being tested?
Radiation and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Sep 2020to 1 Jan 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • CyberKnife Center, Department of Neurosurgery, Huashan Hospital

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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

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.

Being tested
Radiation, Temozolomide
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiationDevice

    Intensity-modulated radiotherapy 20Gy/10fx

  • RadiationDevice

    Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

  • TemozolomideDrug

    Temozolomide 75 mg/m2 concurrently administered with RT.

Study groups in NCT04547621
Study groupRoleWhat they receive
HSRT+IMRT+TemozolomideExperimental* 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.
Receives: Device: Radiation; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Estimated using the Kaplan-Meier method

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

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    Estimated using the Kaplan-Meier method

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

  2. 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.

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

  3. Quality of Life score (QoL)

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

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04547621
Sponsor's protocol ID
KY2020-791
Acronym
HSCK-010
Status last verified
Sep 2020
First submitted
7 Sep 2020
Last updated
14 Sep 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15758009

  • 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.

    PubMed 24895599

  • 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.

    PubMed 26392096

  • 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.

    PubMed 35906549

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiation and Temozolomide in people with Glioma, Malignant, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547621, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.

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