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Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
Diagnosis of glioblastoma confirmed by histology.
  • - 2.
Age: 18-75 years old.
  • - 3.
Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters.
  • - 4.
No prior anticancer therapy for glioblastoma besides biopsy.
  • - 5.
ECOG PS：0-2 point.

Exclusion Criteria:

  • - 1.
Infra-tentorial tumor or tumor involves the ependymal surface.
  • - 2.
Nonmeasurable disease.
  • - 3.
Evidence of uncontrolled intracranial pressure.
  • - 4.
Severe heart, brain, and lung diseases.
  • - 5.
Severe hepatic or renal dysfunction.
  • - 6.
Uncontrolled, active infection.
  • - 7.
Severe clotting dysfunction.
  • - 8.
Pregnant.
  • - 9.
Uncontrolled hypertension.
  • - 10.
Participated in any other clinical treatment trial within 4 weeks before randomization.
  • - 11.
Severe vascular diseases within 6 months before randomization.
  • - 12.
Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04856852
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The Affiliated Hospital of Qingdao University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Xiaokun Hu, MD
Principal Investigator Affiliation The Affiliated Hospital of Qingdao University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

This is a prospective, multicentric open-label trial 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. The primary efficacy outcome was evaluated with progression-free survival (PFS).

Arms & Interventions

Arms

Experimental: Iodine-125+Chemotherapy

Iodine-125; Temozolomide

Active Comparator: Surgical resection+Radiochemotherapy

Surgical resection; Radiotherapy; Temozolomide:

Interventions

Other: - Iodine-125+Chemotherapy

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.

Other: - Surgical resection+Radiochemotherapy

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Xiaokun Hu, PhD

[email protected]

+8618661801166

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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