Glioblastoma
Conditions
Keywords
Glioblastoma, Anlotinib hydrochloride, Stupp regimen, Temozolomide, Radiation therapy, Tyrosine kinase inhibitor
Brief summary
For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
Interventions
DRUGAnlotinib Hydrochloride
Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
RADIATIONRadiation therapy
Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
DRUGTemozolomide
Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Cancer Hospital of Guangxi Medical University
Liuzhou Workers' Hospital
Nanxishan Hospital
LiuZhou People's Hospital
Affiliated Hospital of Guilin University
People's Hospital of Guangxi Zhuang Autonomous Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed and histological proven glioblastoma * Complete gross resection or subtotal resection * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Adequate bone marrow, liver and renal function * Written informed consent
Exclusion criteria
* Meningeal carcinomatosis or spinal compression * Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis * Active, known, or suspected autoimmune disease * Severe allergy to anlotinib or temozolomide * Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases * Uncontrolled mental disorders * High risk of bleeding * Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50% * Contraindicated for MRI examination * Recipient of live vaccine prior to the first dose of anlotinib * Ready for or previously received organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
| Objective response rate | 3 years |
Countries
China
Contacts
Primary ContactHeming Lu, MD
Outcome results
None listed