GlioblastomaPhase 3NCT04829097
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
A Phase 3 study testing Temozolomide in people with Glioblastoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Baorui Liu, Doctor, 13770621908, baoruiliu07@163.com
Juan Du, Doctor, 13951826526, dujunglyy@163.com
About this study
Official title: 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.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideCombination product
Also called Intensity-Modulated Radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| SIB-IMRT | Experimental | 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. Receives: Combination Product: Temozolomide |
| CRT | Active comparator | 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. Receives: Combination Product: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.
Measured: Two years after all treatments are over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829097
- Sponsor's protocol ID
- 2020-307-02
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma
- ClinicalTrials.gov ID
- NCT04829097
- Acronym / sponsor ID
- 2020-307-02
- Conditions
- Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIB-IMRT | Experimental | Combination Product: Temozolomide1. 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. |
| CRT | Active comparator | Combination Product: Temozolomide1. 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: Intensity-Modulated RadiotherapyThe 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. | Combination product | CRT, SIB-IMRT |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temozolomide in people with Glioblastoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yan, Dr. (15805182426, findyoung@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Two years after all treatments are over). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.