NCT04157478

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 464 (estimated)
• Sponsor: People's Hospital of Guangxi Zhuang Autonomous Region · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Anlotinib 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.
RADIATION	Radiation therapy	Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
DRUG	Temozolomide	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-01
• Completion: 2024-12-01
• First posted: 2019-11-08
• Last updated: 2019-11-12

Locations

7 sites across 1 country: China