drugset / Trial / NCT01249352
A Study of Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy. The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.
Timeline
- Start
- 2009-01
- Primary completion
- 2013-11
- Completion
- 2013-11
Outcome
Missed primary endpoint
paper the eCR rates with and without nimotuzumab were 47.2% and 33.3% (P = 0.17), respectively PMID 29179134 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 1000 mg/m2 | Intravenous |