cropped color_logo_with_background.png

Clinical Trial Finder

Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04829097
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

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.

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.

Interventions

Combination Product: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nanjing, Jiangsu, China

Status

Recruiting

Address

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008

Site Contact

Baorui Liu, Doctor

[email protected]

13770621908

Powered By