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

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ClinicalTrials.gov Identifier: NCT04157478
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
First Affiliated Hospital of Guangxi Medical University
Cancer Hospital of Guangxi Medical University
Liuzhou Worker's Hospital
Nanxishan Hospital
Liuzhou People's Hospital
Affiliated Hospital of Guilin University
Information provided by (Responsible Party):
Heming Lu, People's Hospital of Guangxi

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Anlotinib Hydrochloride Radiation: Radiation therapy Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiation therapy, Temozolomide and anlotinib
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). 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.
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.

Active Comparator: Radiation therapy and temozolomide
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).
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.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Objective response rate [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157478


Contacts
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Contact: Heming Lu, MD 86-771-2186-504 gxheminglu@sina.com

Locations
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China, Guangxi
Nanxishan Hospital of Guangxi Zhuang Autonomous Region Not yet recruiting
Guilin, Guangxi, China, 541002
Liuzhou Worker's Hospital Not yet recruiting
Liuzhou, Guangxi, China, 545005
Liuzhou People's Hospital Not yet recruiting
Liuzhou, Guangxi, China, 545006
Affiliated Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
Affiliated Tumor Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
People's Hospital of Guangxi Zhuang Autonomous Region Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Heming Lu, MD    +86-771-218-6503    gxheminglu@sina.com   
Principal Investigator: Heming Lu, MD         
Yulin First Hospital Not yet recruiting
Yulin, Guangxi, China, 537000
Sponsors and Collaborators
People's Hospital of Guangxi
First Affiliated Hospital of Guangxi Medical University
Cancer Hospital of Guangxi Medical University
Liuzhou Worker's Hospital
Nanxishan Hospital
Liuzhou People's Hospital
Affiliated Hospital of Guilin University

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Responsible Party: Heming Lu, Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT04157478     History of Changes
Other Study ID Numbers: GXPH-19001
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heming Lu, People's Hospital of Guangxi:
Glioblastoma
Anlotinib hydrochloride
Stupp regimen
Temozolomide
Radiation therapy
Tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents