GliomaNCT03082846
Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
A study testing hypofractionated radiation and Temozolomide chemotherapy in people with Glioma and Radiotherapy, Intensity-Modulated, run by Xue Xiaoying.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Radiotherapy, Intensity-Modulated, Maximum Tolerated Dose
- What is being tested?
- hypofractionated radiation and Temozolomide chemotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 3 Dec 2016
- Phase
- Interventional
- 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- hypofractionated radiation, Temozolomide chemotherapy
- Keywords
- malignant glioma, intensity modulated radiation therapy, simultaneous integrated boost, hypofractionation, temozolomide, maximum tolerated dose
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiationRadiation
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 chemotherapyDrug
Also called TMZ 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.
| Study group | Role | What they receive |
|---|---|---|
| hypofractionated group | Experimental | 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. Receives: Radiation: hypofractionated radiation; Drug: Temozolomide chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum tolerated dose(MTD)
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.
Measured: 1year
Secondary outcomes (1)
Progression free survival
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Jan 2014
- Primary completion7 Nov 2016
- Study completion3 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xue Xiaoying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xue Xiaoying, The Second Hospital of Hebei Medical University
- Investigators
- xiaoying xue, doctor, Study director, Department of Radiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082846
- Sponsor's protocol ID
- phase I clinical trial-gliomas
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03082846
- Acronym / sponsor ID
- phase I clinical trial-gliomas
- Keywords
- malignant glioma, intensity modulated radiation therapy, simultaneous integrated boost, hypofractionation, temozolomide, maximum tolerated dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Xue XiaoyingUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 3 Dec 2016 (actual)
- First posted
- 17 Mar 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypofractionated group | Experimental | Radiation: hypofractionated radiation, Drug: Temozolomide chemotherapyhypofractionated 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| hypofractionated radiationThe 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. | Radiation | hypofractionated group |
| Temozolomide chemotherapyAlso: TMZ chemotherapyTemozolomide(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. | Drug | hypofractionated group |
Primary outcome
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.
1 secondary outcome
Progression free survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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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.
xiaoying xue, doctor study director
Department of Radiotherapy
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated radiation and Temozolomide chemotherapy in people with Glioma and Radiotherapy, Intensity-Modulated, run by Xue Xiaoying.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the maximum tolerated dose(MTD) (time frame: 1year). 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 21 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.