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Clinical study of hypofractionated simultaneous integrated boost intensity-modulated radiotherapy for postoperative high-grade glioma guided by 3D-MRS combined with neuroanatomy

Clinical study of hypofractionated simultaneous integrated boost intensity-modulated radiotherapy for postoperative high-grade glioma guided by 3D-MRS combined with neuroanatomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014396
Enrollment
Unknown
Registered
2018-01-10
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade glioma

Interventions

Group A:GTV: MRI enhanced regional +MRS anomaly area (tumor area)
CTV1: high signal area + nerve conduction bundle direction GTV+T2 Flair display on 0.5-1cm
CTV2:CTV1+1cm, combined with the anatomical structure of gyri recover
PTV: including PGTV, PCTV1, PCTV2, obtained by the above target. 3mm respectively. Dose, respectively: 66Gy, 60Gy, 54Gy, completed in 27.
Group B:GTV:MRI enhancement area, combined with surgical excision of residual area
CTV1: GTV from external 1cm, combined with the adjacent normal tissue anatomical structure were obtained by modification
CTV2: CTV1 1cm, combined with the adjacent normal tissue anatomical structure of modification
PTV: including PGTV, PCTV1, PCTV2. From above the target area. 3mm dose respectively: 60Gy, 54Gy, 50Gy, completed in 30.

Sponsors

Cancer Institute of PLA, Xinqiao Hospital,Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All the participants in the group must comply with the following criteria: 1. criteria for admission to disease: (1) the postoperatively proved to be a group of high grade glioma (grade WHO III-IV); (2) the expected survival of more than 3 months; (3) KPS score more than 70 points; Hematology, biochemistry and organ function: (1) in the 1 weeks before the random group, the bone marrow and liver and kidney work of the subjects reached the following criteria: Hemoglobin is larger than 100g/L, neutrophil platelet is larger than 1.5*109/L, more than 100*10^9/L; Total bilirubin is less than 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equal to or less than 1.5 times the upper limit of normal; Serum creatinine is less than 1.5 times the upper limit of normal or creatinine clearance rate was higher than 60ml/min, urea nitrogen is less than 200mg/L; (2) women of childbearing age must undergo a test of urine pregnancy within the first 7 days of the beginning and the result is negative, and not in the lactation period. Men and women at childbearing age agreed to adopt a reliable method of contraception before entering the study and in the course of the study until the end of all treatment. 2. general admission criteria: (1) obtain the informed consent signed by the subjects and their legal agents; (2) according to the study program and follow up process, oral medication can be carried out; (3) More than 18 years old and less than 75 years old.

Exclusion criteria

Exclusion criteria: Any of the following exclusionary criteria for this study: 1. the exclusion criteria related to disease: (1) the subjects who had previously received regular radiotherapy had a relapse; (2) to enter the group of other studies; (3) the presence of other cancers and may be expected to affect the survival of the subjects; 2. general exclusion criteria: (1) any unstable systemic diseases including: active infection, uncontrolled hypertension, congestive heart failure, myocardial infarction, severe arrhythmia need drug treatment, liver or kidney metabolic disease, neuropathy / mental disorders such as Blzheimer's disease; (2) the known human immunodeficiency virus (HIV) infection; (3) according to the researchers' judgement, there are serious diseases that are harmful to the safety of the subjects, or the accompanying diseases that affect the subjects' completion of the study, and the compliance of the subjects.

Design outcomes

Primary

MeasureTime frame
Tumor size;

Countries

China

Contacts

Public ContactLi Guang-hui

Radiotherapy center of the oncology department of Xinqiao Hospital, Shapingba District, Chongqing

liguanghui_2000@aliyun.com+86 13996181950

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026