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Prospective, randomized, controlled and multicenter trial for the efficacy and safety of S-1 in the treatment of locally advanced nasopharyngeal carcinoma

Prospective, randomized, controlled and multicenter trial for the efficacy and safety of S-1 in the treatment of locally advanced nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015670
Enrollment
Unknown
Registered
2018-04-13
Start date
2018-04-13
Completion date
Unknown
Last updated
2018-04-30

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

Sponsors

Jiangsu Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old; 2. pathologically diagnosed as differentiated and undifferentiated type of non-angular Huafing nasopharyngeal carcinoma; 3. Clinical staging is T3-4N0-2M0, T1-4N2-3M0 (except T3N0 according to the 7th edition UICC staging Standard), a first-line scheme has been adopted (TP/TPF/ PF) induction or synchronous chemotherapy in 2-4 weeks, the curative effect of radical radiotherapy at the end of the treatment was CR/PR/SD; 4. Baseline laboratory tests meet the following criteria: Bone marrow function: WBC=4.0x10^9/L,ANC=2.0x10^9/L,PLT=100x10^9/L, Hb=90g/L; Liver function: Total bilirubin =ULN,AST, ALT=ULNx2.5, alkaline phosphatase =ULNx5, Kidney function: serum creatinine (Cr) =ULN and ccr=60 ml/min (using Cockcroft-gault formula); Cardiac function: ECG is basically normal; 5. Expected survival time = 12 months; 6. KPS score =70; 7. Patients or their legal representatives voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with PD at the end of radiotherapy; 2. Patients who used targeted drugs 3. Patients who have been treated with a non-front-line regimen 4. Known to be allergic to S-1 5. Malignant neoplasm of other histological sources other than nasopharyngeal malignancies 6. Pregnant, lactating women 7. Any serious complication

Design outcomes

Primary

MeasureTime frame
No disease progression survival;No recurrence survival rate of lymph nodes ;No distant metastasis survival period;Overall survival;

Countries

China

Contacts

Public ContactXia He

Jiangsu Provincial Cancer Hospital

hexia2003@tom.com+86 13601458518

Outcome results

None listed

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