- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388372
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
December 24, 2017 updated by: Shao Xiong Wu, Biotech Pharmaceutical Co., Ltd.
Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong, China
- Guangdong Brain Hospital
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Guangdong, China
- The First Affiliated Hospital/School of Clinical Medicine of Guangdong
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Guangzhou, China
- The First Affiliated Hospital of Guangzhou Medical University
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Shenzhen, China
- Shenzhen People's Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
- EGFR positive;
- >50% of the gross tumor volume removed by surgery;
- Karnofsky performance score (KPS) ≥ 60;
- Adequate renal function (creatinine ≤1.5×upper limit of normal [ULN] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
- Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
- An interval of 2 to 6 weeks between surgery and RT was required.
Exclusion Criteria:
- Negative EGFR expression;
- Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
- Patients with severe complications or active infection;
- Continuous vomiting that could interfere with the oral administration of TMZ;
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 2 years
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PFS will be calculated as the time from surgery to the date of progression-free.
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2 years
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Overall survival (OS)
Time Frame: 2 years
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OS will be calculated as the time from surgery to the date of death.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 6 months
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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.
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6 months
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Incidence of adverse events
Time Frame: 6 months
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Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shao-Xiong Wu, Professor, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2010
Primary Completion (Actual)
March 23, 2017
Study Completion (Actual)
March 23, 2017
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 24, 2017
First Posted (Actual)
January 3, 2018
Study Record Updates
Last Update Posted (Actual)
January 3, 2018
Last Update Submitted That Met QC Criteria
December 24, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Temozolomide
- Nimotuzumab
Other Study ID Numbers
- NimotuzumabGBM2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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