- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082846
Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
March 17, 2017 updated by: Xue Xiaoying
Treatment of High-grade Gliomas Using Escalating Doses of Hypofractionated Simultaneous Integrated Boost-intensity Modulated Radiation Therapy in Combination With Temozolomide - a Modified Phase I Clinical Trial
Postoperative conventional radiation at 60 Gy/30f is currently still considered the standard radiotherapy mode for high-grade gliomas; however, the efficacy is still unsatisfactory.
Studies in recent years have shown that hypofractionated simultaneous integrated boost-intensity modulated radiation therapy (SIB-IMRT) has certain survival benefits over other fractionation methods; but, the best hypofractionation mode and its efficacy have not been confirmed.
The purpose of this study is to investigate the maximum tolerated dose (MTD) of hypofractionated SIB-IMRT with stepwise escalating of doses combined with temozolomide (TMZ) for the treatment of malignant gliomas.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Background: Postoperative conventional radiation at 60 Gy/30f is currently still considered the standard radiotherapy mode for high-grade gliomas; however, the efficacy is still unsatisfactory.
Studies in recent years have shown that hypofractionated simultaneous integrated boost-intensity modulated radiation therapy (SIB-IMRT) has certain survival benefits over other fractionation methods; but, the best hypofractionation mode and its efficacy have not been confirmed.
The purpose of this study is to investigate the maximum tolerated dose (MTD) of hypofractionated SIB-IMRT with stepwise escalating of doses combined with temozolomide (TMZ) for the treatment of malignant gliomas.
Methods: Malignant gliomas patients receive concurrent postoperative radiotherapy and chemotherapy.
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.
The planning target volume (PTV2) including the 2cm region around surgical cavity and residual tumor remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f.
The subsequent group of patients is advanced to the next dose level until dose-limiting toxicity (DLT) is present.
The dose, one level lower than the DLT, is the MTD.
The highest target single dose is 4 Gy/f.
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
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:
- Postoperative grades III and IV glioma patients confirmed by pathology.
- The ages are between 18-70 years.
- Karnofsky performance score(KSP)≧60.
- Expected survival period ≧3 months.
- Blood routine and liver and kidney functions are normal.
- Receive cranial MRI examination after 48 h of surgery.
- Radiotherapy is performed after 2-4 weeks of surgery.
- Patients with restricted lesions and non-diffuse growth.
- Maximum diameter of the residual tumor, surgical cavity, and primary tumor bed are ≦6 cm.
Exclusion Criteria:
- Lesions are in the brain stem and thalamus.
- Pregnant and lactating women.
- Secondary primary malignant tumor.
- Severe pulmonary infection.
- Combination with mental illness or another disease that require hospitalization.
- Patients had received chemotherapy or brain radiotherapy previously.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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(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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the maximum tolerated dose(MTD)
Time Frame: 1year
|
Safety and tolerability of hypofractionated simultaneous integrated boost intensity modulated radiation therapy (SIB-IMRT) combined with standard temozolomide chemotherapy. The maximum tolerated dose of hypofractionated radiation combined with concurrent temozolomide in newly diagnosed highgrade glioma is being explored. |
1year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 1 year
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: xiaoying xue, doctor, Department of Radiotherapy
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)
January 1, 2014
Primary Completion (Actual)
November 7, 2016
Study Completion (Actual)
December 3, 2016
Study Registration Dates
First Submitted
February 22, 2017
First Submitted That Met QC Criteria
March 12, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
March 21, 2017
Last Update Submitted That Met QC Criteria
March 17, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- phase I clinical trial-gliomas
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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