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Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma

NCT04829097•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: 18 to 70 years old
•A patient with high-grade (WHO grade IV) glioma diagnosed pathologically
•ECOG score ≤ 3 points
•The expected survival time is greater than 3 months
•Patients undergoing surgery for the first time
•Patients who have not received radiotherapy at the treatment site in the past
•The following hematological indicators need to be met Neutrophil count ≥1.5×109/L Hemoglobin ≥9g/dL Platelet count ≥70×109/L
•The following biochemical indicators need to be met Total bilirubin≤1.5×upper limit of normal (ULN) AST and ALT\<1.5×ULN Creatinine clearance rate ≥60ml/min
•Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial
•The signed informed consent form
+1 more criteria

Exclusion Criteria

•Patients with recurrent glioma who have previously undergone surgery or radiotherapy and chemotherapy
•Glioma of the spinal cord
•ECOG score\> 3 points
•Severe mental symptoms; uncontrollable status epilepticus
•Patients with malignant tumors in other parts
•The patient has an active bacterial, viral or fungal infection (≥ Grade 2 NCI-CTC, 4th edition)
•The patient has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the researcher thinks cannot be included in the group
•Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days before joining the group
•Drug abuse, clinical, psychological or social factors affect informed consent or research implementation
•Any uncertain factors that affect the safety or compliance of patients

Locations (1)

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Key Dates

Start Date

November 1, 2020

Primary Completion Date

November 1, 2023

Completion Date

November 1, 2023

Last Updated

April 2, 2021

Enrollment

ESTIMATED participants

Conditions

Glioblastoma

Interventions

Temozolomide

COMBINATION_PRODUCT

Contacts

Jing Yan, Dr.

CONTACT

15805182426 findyoung@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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