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A multicenter, randomized, controlled, noninferior clinical study of reduced-concurrent chemotherapy for locally advanced nasopharyngeal carcinoma based on tumor response

A multicenter, randomized, controlled, noninferior clinical study of reduced-concurrent chemotherapy for locally advanced nasopharyngeal carcinoma based on tumor response

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056868
Enrollment
Unknown
Registered
2022-02-21
Start date
2021-03-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Nasopharygneal carcinoma

Interventions

Experimental group:radiation therapy

Sponsors

Cancer Center, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. At initial diagnosis and histopathological diagnosis, the pathological type was non-keratinizing carcinoma (according to the World Health Organization, WHO pathological classification). 2. Staging is III-IVa (according to the eighth edition of AJCC Staging standards). 3. No evidence of distant metastasis (M0). 4. Functional status: Karnofsky scale (KPS) > 70. 5. Normal bone marrow function: white blood cell count > 4x10^9/L, hemoglobin > 90g/L and platelet count > 100x10^9/L. 6. Normal liver function: total bilirubin = 60 mL/min(according to Cockcroft-Gault formula) or serum creatinine = 50% (according to RECIST, version 1.1), plasma EBV DNA decreased to 0 copies/mL. 9. Patients must be informed of the basic content of the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. The pathological type was WHO keratinizing squamous cell carcinoma or basal squamous cell carcinoma. 2. Aged > 65 years or < 18 years. 3. Treatment is palliative. 4. Previous history of malignant tumor. Exceptions are adequately treated basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix. 5. Pregnant or lactating patients (consider pregnancy tests for women of child-bearing age; Effective contraception should be emphasized during treatment). 6. Previous radiation therapy (except for non-melanoma skin cancer with previous lesions outside the radiation target area).

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Incidence of acute and late toxiciity;Quality of life;Local replase-free survival;

Countries

China

Contacts

Public ContactMao Yanping

Sun Yat-sen University

maoyp@sysucc.org.cn+86 13500019575

Outcome results

None listed

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