Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
NCT ID: NCT03082846
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2014-01-01
2016-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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hypofractionated group
hypofractionated group using hypofractionated radiation with temozolomide chemotherapy: Malignant gliomas patients received concurrent postoperative radiotherapy and chemotherapy.Intensity-modulated radiotherapy is adopted, the dose at each fraction is gradually increased from 2.8 Gy/f (total of 20 times) with an escalating dose interval of 0.4 Gy in PTV1. The planning target volume (PTV2) remain unchanged with 2.5 Gy each time and a total of 50 Gy/20 f. Temozolomide is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.
hypofractionated radiation
The simultaneous integrated boost-intensity modulated technology is adopted to increase both the dose in the surgical cavity and residual tumor (PTV1).The dose at each fraction is gradually increased from 2.8 Gy/f (total of 20 times) with an escalating dose interval of 0.4 Gy in PTV1, until dose-limiting toxicity is present,the highest target single dose is 4 Gy/f. The planning target volume (PTV2) including the 2 cm region around surgical cavity and residual tumor remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f.
Temozolomide chemotherapy
Temozolomide(TMZ) is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.
Interventions
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hypofractionated radiation
The simultaneous integrated boost-intensity modulated technology is adopted to increase both the dose in the surgical cavity and residual tumor (PTV1).The dose at each fraction is gradually increased from 2.8 Gy/f (total of 20 times) with an escalating dose interval of 0.4 Gy in PTV1, until dose-limiting toxicity is present,the highest target single dose is 4 Gy/f. The planning target volume (PTV2) including the 2 cm region around surgical cavity and residual tumor remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f.
Temozolomide chemotherapy
Temozolomide(TMZ) is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The ages are between 18-70 years.
3. Karnofsky performance score（KSP）≧60.
4. Expected survival period ≧3 months.
5. Blood routine and liver and kidney functions are normal.
6. Receive cranial MRI examination after 48 h of surgery.
7. Radiotherapy is performed after 2-4 weeks of surgery.
8. Patients with restricted lesions and non-diffuse growth.
9. Maximum diameter of the residual tumor, surgical cavity, and primary tumor bed are ≦6 cm.
Exclusion Criteria
2. Pregnant and lactating women.
3. Secondary primary malignant tumor.
4. Severe pulmonary infection.
5. Combination with mental illness or another disease that require hospitalization.
6. Patients had received chemotherapy or brain radiotherapy previously.
18 Years
70 Years
ALL
No
Sponsors
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Xue Xiaoying
OTHER
Responsible Party
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Xue Xiaoying
Department of Radiotherapy
Principal Investigators
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xiaoying xue, doctor
Role: STUDY_DIRECTOR
Department of Radiotherapy
Other Identifiers
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phase I clinical trial-gliomas
Identifier Type: -
Identifier Source: org_study_id
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