Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
NCT00702481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2023-02-28
Summary
The purpose of this study is to define the response and toxicities with the addition of Nimotuzumab to chemoradiation for head and neck cancer.
Conditions
Interventions
- DRUG
-
Nimotuzumab
Patients will receive nimotuzumab 200 mg weekly for 8 weeks. Nimotuzumab will be started together with concurrent chemoradiation, and continued 1 week after the completion of chemoradiation.
- DRUG
-
Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.
- RADIATION
-
Radiation
Concurrent radiotherapy will be given to the primary tumor and upper neck at 2 Gy per fraction, once a day, five days a week to a total of 70 Gy in 35 fractions in seven weeks.
Sponsors & Collaborators
-
Innogene Kalbiotech Pte. Ltd
collaborator INDUSTRY -
National Cancer Centre, Singapore
lead OTHER
Principal Investigators
-
Wan-Teck Lim, MD · National Cancer Center Singapore
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-28
- Primary Completion
- 2019-09-03
- Completion
- 2019-09-03
Countries
- Singapore
Study Locations
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