NCT04856852

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

April 20, 2021

Last Update Submit

June 28, 2021

Conditions

Glioblastoma

Keywords

GlioblastomaIodine-125Surgical resectionRadiochemotherapyChemotherapyRadiation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated.

    2.5 years after randomization

Secondary Outcomes (5)

  • Overall Survival (OS)

    2.5 years after randomization

  • Survival rates at 6 months and 1 year

    at 6 months and 1 year after operation respectively

  • EORTC QLQ-C30

    2.5 year after randomization

  • ECOG Performance Status

    2.5 year after randomization

  • Complications

    within 1 week after operation

Study Arms (2)

Iodine-125+Chemotherapy

EXPERIMENTAL

Iodine-125; Temozolomide

Other: Iodine-125+Chemotherapy

Surgical resection+Radiochemotherapy

ACTIVE COMPARATOR

Surgical resection; Radiotherapy; Temozolomide:

Other: Surgical resection+Radiochemotherapy

Interventions

Iodine-125+ChemotherapyOTHER

Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.

Also known as: Iodine-125+Temozolomide
Iodine-125+Chemotherapy
Surgical resection+RadiochemotherapyOTHER

Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection. Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.

Also known as: Surgical resection+Radiotherapy+Temozolomide
Surgical resection+Radiochemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Diagnosis of glioblastoma confirmed by histology
  • \. Age: 18-75 years old
  • \. Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters
  • \. No prior anticancer therapy for glioblastoma besides biopsy.
  • \. ECOG PS：0-2 point

You may not qualify if:

  • \. Infra-tentorial tumor or tumor involves the ependymal surface.
  • \. Nonmeasurable disease.
  • \. Evidence of uncontrolled intracranial pressure.
  • \. Severe heart, brain, and lung diseases.
  • Severe hepatic or renal dysfunction.
  • \. Uncontrolled, active infection.
  • \. Severe clotting dysfunction.
  • \. Pregnant.
  • \. Uncontrolled hypertension.
  • \. Participated in any other clinical treatment trial within 4 weeks before randomization.
  • \. Severe vascular diseases within 6 months before randomization.
  • \. Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Xiaokun Hu, MD

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaokun Hu, PhD

CONTACT

+8618661801166huxiaokun770@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

June 28, 2021

Primary Completion

August 1, 2022

Study Completion

August 31, 2023

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share