A Phase 2 interventional study of nimotuzumab and PF regimen (cisplatin and 5-FU) in Head and Neck Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-02-20.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 40 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
nimotuzumab plus PF regimen
Drug: nimotuzumab · Drug: PF regimen (cisplatin and 5-FU)
nimotuzumab 400 mg d1
Also known as: h-R3
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Also known as: PF
overall response rate
Time frame: 6 weeks
pathologic complete response
Time frame: 8 weeks
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Fudan University