Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial

NCT03082846 | Completed DMC

• 1 other identifier: phase I clinical trial-gliomas
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Glioma; Radiotherapy, Intensity-Modulated; Maximum Tolerated Dose

Keywords

malignant glioma; intensity modulated radiation therapy; simultaneous integrated boost; hypofractionation; temozolomide; maximum tolerated dose

Outcome Measures

Primary Outcomes (1)

• 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.

  1year

Secondary Outcomes (1)

• Progression free survival

  1 year

Study Arms (1)

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.

Radiation: hypofractionated radiation; Drug: Temozolomide chemotherapy

Interventions

hypofractionated radiation 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.

hypofractionated group

Temozolomide chemotherapy DRUG

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.

Also known as: TMZ chemotherapy

hypofractionated group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xue Xiaoying: lead

MeSH Terms

Conditions

Glioma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• xiaoying xue, doctor

  Department of Radiotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Radiotherapy

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 17, 2017
• Study Start: January 1, 2014
• Primary Completion: November 7, 2016
• Study Completion: December 3, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share