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A prospective randomized controlled clinical trial of docetaxel plus cisplatin induction chemotherapy 2 or 3 cycle followed by concurrent chemoradiotherapy in the treatment of locally localized advanced nasopharyngeal carcinoma

A prospective randomized controlled clinical trial of docetaxel plus cisplatin induction chemotherapy 2 or 3 cycle followed by concurrent chemoradiotherapy in the treatment of locally localized advanced nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012529
Enrollment
Unknown
Registered
2017-09-01
Start date
2017-09-07
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

Nasopharyngeal carcinoma

Interventions

A:docetaxel plus cisplatin induction chemotherapy 2 cycle followed by concurrent chemoradiotherapy
B:docetaxel plus cisplatin induction chemotherapy 3 cycle followed by concurrent chemoradiotherapy

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, between 18-65 years old; 2. ECOG PS: 0 or 1; 3. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III; 4. Patients newly diagnosised without history of anti-tumor treament (Original clinical staged as III-IVa except T3N1 T3-4N0, according to the 8th AJCC edition); 5. At least one radiographically documented lesion assessable according to RECIST criteria 1.1; 6. Expected lifetime=6 months; 7. Good function of the main functional organs: 1) blood routine examination:white blood cell=3.5×10^9/ L,neutrophils=1.5×10^9/L, platelet count=100×10^9/L; Haemoglobin=90g/L; 2) biochemical tests: STB and CB=1.5×ULN, ALT and AST=2.5×ULN, ALP=2.5×ULN, Ccr=50mL/min; 8. Voluntary to participate and sign informed consent document, compliance with regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Previously treated including surgery, chemotherapy, radiotherapy(except diagnostic treatment); 2. Palliative intent; 3. History of other cancer; 4. Pregnant or lactating women; 5. Associated with other serious diseases, may bring great risk or affect the compliance test. For example: active tuberculosis; unstable heart disease, kidney disease, liver disease, diabetes control is not ideal (fasting blood glucose > 1.5 * ULN), and mental illness; 6. The researchers believe the case is inappropriate.

Design outcomes

Primary

MeasureTime frame
Progress-free survival;—

Secondary

MeasureTime frame
Overall Survival(OS);distant failure-free survival, D-FFS;locoregional failure-free survival, LR-FFS;—

Countries

China

Contacts

Public ContactShen Liangfang

Xiangya Hospital of Central South University

slf1688@sina.com+86 13975805137

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026