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Nimotuzumab combined cisplatin, 5-fluorouracil neoadjuvant chemotherapy follow by cisplatin synchronous intensity-modulated radiotherapy in locally advanced nasopharyngeal carcinoma: a multicenter, prospective phase II study

Nimotuzumab combined cisplatin, 5-fluorouracil neoadjuvant chemotherapy follow by cisplatin synchronous intensity-modulated radiotherapy in locally advanced nasopharyngeal carcinoma: a multicenter, prospective phase II study

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008201
Enrollment
Unknown
Registered
2016-03-31
Start date
2015-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced nasopharyngeal carcinoma

Interventions

Experimental group:Nimotuzumab combined cisplatin, 5-fluorouracil neoadjuvant chemotherapy

Sponsors

The fourth affiliated hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Newly diagnosed patients do not undergo radiotherapy, chemotherapy before clinical trials begin; 2) The histopathological diagnosis of nasopharyngeal carcinoma; 3) Clinical stage III-IVa (2008)/III b-IV stage (AJCC 2009); 4) There are measurable lesions by RECIST criteria; 5) Aged 18-70 years.

Exclusion criteria

Exclusion criteria: 1) Cognitive dysfunction; 2) Patients with distant metastases; 3) Patients with any other cancer in 5 years; 4) Any other disease or condition for chemotherapy and radiotherapy contraindications (such as active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or arrhythmias that are not controlled, immunosuppressive therapy); 5) Women without using contraception during pregnancy and lactation,or fertility; 6) Bone marrow dysfunction; 7) Patients with bleeding tendency; 8) Drug abuse and alcohol addiction; 9) Patients having 3 or 4 allergic reactions for any drugs in the study.

Design outcomes

Primary

MeasureTime frame
Disease remission rate;adverse reactions;overall survival;

Countries

China

Contacts

Public ContactHai-xin HUANG

The fourth affiliated hospital of Guangxi Medical University

13507726193@163.com+86 13507726193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026