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Comparison the effects of different neoadjuvant chemotherapy regimen on acute toxicity, tumor response, and survival in patients with advanced nasopharyngeal carcinoma

Comparison the effects of different neoadjuvant chemotherapy regimen on acute toxicity, tumor response, and survival in patients with advanced nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006378
Enrollment
Unknown
Registered
2015-05-09
Start date
2015-07-01
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

nasopharyngeal carcinoma

Interventions

Experimental:cisplatin and 5-FU chemotherapy once a week
Control:Traditional PF chemotherapry once three week

Sponsors

Fujian Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age 20-70 years old; 2. Patients with histologically confirmed as nasopharyngeal carcinoma; 3. Patients with stage III-IVb according to 7th AJCC staging system, with the life expectancy of more than or equal to 12 months; 4. Patients who are suitable for and tolerate to chemo-radiotherapy; 5. At least one radiographically documented lesion assessable according to RECIST solid tumor criteria by MRI; 6. Patients with ECOG score of 0-1; 7. Haemoglobin >=90g/L, neutrophils >=1.5*10^9/L, platelet count >=100*10^9/L; 8. Hepatic function: ALT and AST< 3*ULN, TBIL<2.0*ULN.

Exclusion criteria

Exclusion criteria: Previous radiotherapy; 4) Currently receive radiotherapy, which is part of treatment protocols after the resection of primary tumor; 5) Clinically significant ongoing infection (Need intravenous antibiotics), including active TB, and/or confirmed HIV infection; 6) Un-controlled diatebes, pulmonary fibrosis, serious lung disease, interstitial pneumonia, heart and liver failure; 7) Un-controlled hypertension (systolic blood pressure >=180 mmHg, and/or diastolic blood pressure >=130 mmHg under the sedentary condition); 8) Pregnant (should be excluded by detection of HCG) or breast-feeding women; 9) History of coronary heart disease and myocardial infarction within 12 months, or presented with high risk factors of un-controlled arrhythmia or cardiac insufficiency; 10) Previously Participate in other drug interventional clinical trials.

Design outcomes

Primary

MeasureTime frame
Acute toxicity reaction;

Secondary

MeasureTime frame
Remission Rate;5-year survival rate;

Countries

TAIWAN CHINA

Contacts

Public ContactLin Shaojun
linshaojun@yeah.net+86 13860603879

Outcome results

None listed

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