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Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • The Affiliated Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIB-IMRT

CRT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Objective response rate
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2021
Last Updated
March 30, 2021
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04829097
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIB-IMRT
Arm Type
Experimental
Arm Description
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.
Arm Title
CRT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Intensity-Modulated Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.
Time Frame
Two years after all treatments are over

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Yan, Dr.
Phone
15805182426
Email
findyoung@126.com
Facility Information:
Facility Name
The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baorui Liu, Doctor
Phone
13770621908
Email
baoruiliu07@163.com
First Name & Middle Initial & Last Name & Degree
Juan Du, Doctor
Phone
13951826526
Email
dujunglyy@163.com

12. IPD Sharing Statement

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Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

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