- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829097
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
March 30, 2021 updated by: Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Yan, Dr.
- Phone Number: 15805182426
- Email: findyoung@126.com
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210008
- Recruiting
- The Affiliated Hospital of Nanjing University Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Two years after all treatments are over
|
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.
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Two years after all treatments are over
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2020
Primary Completion (ANTICIPATED)
November 1, 2023
Study Completion (ANTICIPATED)
November 1, 2023
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
March 30, 2021
First Posted (ACTUAL)
April 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 2, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- 2020-307-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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