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Clinical Trials in China / NCT05979961
Active, not recruiting Phase 3

Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

NCT05979961 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2023-09-07
Last updated
2026-08-12

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

IMRT and concurrent cisplatingemcitabine and cisplatin (Induction chemotherapy) →

IMRT and concurrent cisplatin: Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)

gemcitabine and cisplatin (Induction chemotherapy): Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy

Study summary

The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-70 years old. 2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). 3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml. 4. ECOG Performance status less or equal to 1. 5. Male and no pregnant female. 6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. 7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN. 8. Adequate renal function: creatinine clearance ≥ 60 ml/min. 9. Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: 1. Patients have evidence of relapse or distant metastasis. 2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 3. Treatment with palliative intent. 4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). 5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Guangzhou Panyu Central Hospital Guangzhou Guangdong
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Zhongshan City People's Hospital Zhongshan Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Cancer Hospital of Guizhou Province Guiyang Guizhou
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology; Wuhan Hubei
Hunan Cancer Hospital Changsha Hunan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05979961 on ClinicalTrials.gov ↗ ← All trials in China