Clinical trial NCT04829097: Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
Official title: A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glioblastoma
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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
* Ability to follow research protocols and follow-up procedures

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

Primary outcomes:
measure: Objective response rate
timeFrame: Two years after all treatments are over
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: