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Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Primary Purpose

Glioblastoma

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hypofractionated radiotherapy
Conventional radiotherapy
Temozolomide
Sponsored by
Seoul National University Boramae Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

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

Inclusion Criteria:

  • newly diagnosed glioblastoma according to the 2021 World Health Organization classification
  • interval of ≤4 weeks between pathological diagnosis and randomization
  • aged 70 years or older
  • gadolinium-enhanced MRI within 72 hours of surgery
  • known o6-methylguanine-DNA-methyltransferase promoter methylation status
  • Karnofsky performance score ≥60
  • stable or decreasing dose of steroid (if necessary)
  • no history of brain radiotherapy
  • no history of any systemic chemotherapy
  • adequate hematological, renal and hepatic functions for temozolomide
  • able to start radiotherapy within 3 weeks from randomization

Exclusion Criteria:

  • patients with spinal leptomeningeal carcinomatosis
  • history of cancer other than the followings:
  • carcinoma in situ of the cervix
  • completely excised non-melanoma skin cancer
  • cancers without any evidence of residual disease for 5 years or longer
  • patients with serious active infection or other serious underlying medical conditions
  • patients with psychological issues that cannot comply to the protocol
  • patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
  • patients who are currently participating in other clinical trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Hypofractionated radiochemotherapy

    Conventional radiochemotherapy

    Arm Description

    Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

    Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

    Outcomes

    Primary Outcome Measures

    Overall survival
    from randomization

    Secondary Outcome Measures

    progression-free survival
    from randomization
    treatment-related toxicity
    any treatment-related toxicity
    patient-reported quality of life
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 version 3.0): range, 0-100 (a high score for a functional scale represents a high / healthy level of functioning; a high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems) Quality of Life Questionnaire-Brain Neoplasm (EORTC QLQ-BN20): range, 20-80; lower score means better outcome

    Full Information

    First Posted
    June 21, 2022
    Last Updated
    June 27, 2022
    Sponsor
    Seoul National University Boramae Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05439278
    Brief Title
    Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
    Official Title
    Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    July 31, 2025 (Anticipated)
    Study Completion Date
    July 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Boramae Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    268 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypofractionated radiochemotherapy
    Arm Type
    Experimental
    Arm Description
    Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
    Arm Title
    Conventional radiochemotherapy
    Arm Type
    Experimental
    Arm Description
    Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
    Intervention Type
    Radiation
    Intervention Name(s)
    Hypofractionated radiotherapy
    Intervention Description
    40.05 Gy in 15 fractions (daily treatment, 5 per week)
    Intervention Type
    Radiation
    Intervention Name(s)
    Conventional radiotherapy
    Intervention Description
    60 Gy in 30 fractions (daily treatment, 5 per week)
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Intervention Description
    concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
    Primary Outcome Measure Information:
    Title
    Overall survival
    Description
    from randomization
    Time Frame
    follow-up until 2 years
    Secondary Outcome Measure Information:
    Title
    progression-free survival
    Description
    from randomization
    Time Frame
    follow-up until 2 years
    Title
    treatment-related toxicity
    Description
    any treatment-related toxicity
    Time Frame
    follow-up until 2 years
    Title
    patient-reported quality of life
    Description
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 version 3.0): range, 0-100 (a high score for a functional scale represents a high / healthy level of functioning; a high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems) Quality of Life Questionnaire-Brain Neoplasm (EORTC QLQ-BN20): range, 20-80; lower score means better outcome
    Time Frame
    follow-up until 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed glioblastoma according to the 2021 World Health Organization classification interval of ≤4 weeks between pathological diagnosis and randomization aged 70 years or older gadolinium-enhanced MRI within 72 hours of surgery known o6-methylguanine-DNA-methyltransferase promoter methylation status Karnofsky performance score ≥60 stable or decreasing dose of steroid (if necessary) no history of brain radiotherapy no history of any systemic chemotherapy adequate hematological, renal and hepatic functions for temozolomide able to start radiotherapy within 3 weeks from randomization Exclusion Criteria: patients with spinal leptomeningeal carcinomatosis history of cancer other than the followings: carcinoma in situ of the cervix completely excised non-melanoma skin cancer cancers without any evidence of residual disease for 5 years or longer patients with serious active infection or other serious underlying medical conditions patients with psychological issues that cannot comply to the protocol patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide patients who are currently participating in other clinical trials
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chan Woo Wee, MD, PhD
    Phone
    +82-2-870-1695
    Email
    wcw0108@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chan Woo Wee, MD, PhD
    Organizational Affiliation
    SMG-SNU Boramae Medical Center
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    In Ah Kim, MD, PhD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to make individual participant data available.

    Learn more about this trial

    Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

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