Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

NCT ID: NCT04829097

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-11-01

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIB-IMRT

1\. New auxiliary TMZ period: oral TMZ 75mg/m2, qd, continued until the beginning of radiotherapy. 2. Concurrent radiotherapy and chemotherapy period: 4 weeks in total. Prior to treatment, radiotherapy positioning and planning were established, using SIB-IMRT technology, the irradiation range, the tumor residual area 60Gy/20f/4w, the tumor bed area 40Gy/20f/4w, 1 time/d, 5 times/w. During radiotherapy, TMZ will continue to be administered orally simultaneously, the specific dose: TMZ 75mg/m2 qd, until 42 days. 3. Intermediate rest period: 4 weeks in total. ;4. TMZ adjuvant chemotherapy period: 6 to 12 months in total. Cycle 1: TMZ 150mg/m2, d1-5, q28d; if the patient can tolerate it, cycles 2-12: TMZ 200mg/m2, d1-5, q28d; after cycles 3, 6, 9, and 12 of adjuvant chemotherapy Head functional magnetic resonance examination was performed to assess the size of residual lesions and edema.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: COMBINATION_PRODUCT

The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.

CRT

1\. Concurrent radiotherapy and chemotherapy period: 6 weeks in total. Radiotherapy positioning and planning before treatment, using CRT technology, irradiation range, tumor bed area, 60Gy/30f/6w, 1 time/d, 5 times/w, simultaneous TMZ oral administration on the first day of radiotherapy, specific dose: TMZ 75mg/m2 qd for 42 consecutive days; head functional magnetic resonance imaging was performed at the end of radiotherapy to assess the size of residual lesions and edema. 2. Intermediate rest period: 4 weeks in total. The patient will go to the hospital to recheck blood routine every week;3. TMZ adjuvant chemotherapy period: 6 to 12 months in total. Cycle 1: TMZ 150mg/m2, d1-5, q28d; if the patient can tolerate it, cycles 2-12: TMZ 200mg/m2, d1-5, q28d; head functional magnetic resonance imaging was performed after adjuvant chemotherapy in cycles 3, 6, 9, and 12 to assess the size of residual lesions and edema.

Group Type: ACTIVE_COMPARATOR

Temozolomide

Intervention Type: COMBINATION_PRODUCT

The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.

Interventions

Temozolomide

The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Intensity-Modulated Radiotherapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Yang Yang

Professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Yan, Dr.

Role: CONTACT

findyoung@126.com

15805182426

Facility Contacts

Baorui Liu, Doctor

Role: primary

baoruiliu07@163.com

13770621908

Juan Du, Doctor

Role: backup

dujunglyy@163.com

13951826526

Other Identifiers

2020-307-02

Identifier Type: -

Identifier Source: org_study_id