Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.

Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.

Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.

Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.

Radiotherapy

Shao-Xiong Wu, Professor

This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.

Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma

PFS will be calculated as the time from surgery to the date of progression-free.

OS will be calculated as the time from surgery to the date of death.

ORR: overall response rate (ORR), subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use.

Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma	NCT03388372	Glioblastoma	Nimotuzumab Temozolomide Radiotherapy	18 Years - 75 Years	Biotech Pharmaceutical Co., Ltd.
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma	NCT03388372	Glioblastoma	Nimotuzumab Temozolomide Radiotherapy	18 Years - 75 Years	Biotech Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for nimotozumab

Every month we try and update this database with for nimotozumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nimotozumab

Every month we try and update this database with for nimotozumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nimotozumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.