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OncoMatch/Clinical Trials/NCT05979961

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

Is NCT05979961 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies gemcitabine and cisplatin (Induction chemotherapy) for nasopharyngeal carcinoma.

Phase 3RecruitingSun Yat-sen UniversityNCT05979961Data as of May 2026

Treatment: gemcitabine and cisplatin (Induction chemotherapy)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).

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: EBV plasma EB Virus DNA <4000 copies/ml (<4000 copies/ml)

pretreatment plasm EB Virus DNA<4000copies/ml

Disease stage

Required: Stage III, IVA

Excluded: Stage T4N2, ANYTN3

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Exception: except for non-melanomatous skin cancers outside intended RT treatment volume

History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume)

Cannot have received: chemotherapy

Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes

Cannot have received: surgery

Exception: except diagnostic

Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes

Lab requirements

Blood counts

leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL

Kidney function

creatinine clearance ≥ 60 ml/min

Liver function

ALT, AST < 1.5×ULN concomitant with ALP < 2.5×ULN, and bilirubin < ULN

Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. Normal liver function test: ALT, AST < 1.5×ULN concomitant with ALP < 2.5×ULN, and bilirubin < ULN. Adequate renal function: creatinine clearance ≥ 60 ml/min.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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