OncoMatch/Clinical Trials/NCT04898374
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma
Is NCT04898374 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Gemcitabin/cisplatin for nasopharyngeal carcinoma.
Treatment: Gemcitabin/cisplatin — The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation(CRT).Recent advances in radiation techniques and supportive measures resulted in improvemnent of locoregional control and quality of life.However distant failure is still the main challenging reason of poor survival Addition of systemic therapy to concurrent CRT is widely used and accepted as an option to reduce these failures ,however selection of chemotherapy regimen and timing in relation to CRT is controversial. Doublet and triplet chemotherapy regimens using cisplatin and 5FU are throughly investigated in this setting.Inspite of significant improvement in disease free survival and overall survival they were poorly tolerated.Hence,minority of patients in the daily practice could tolerate those studied regimens as propsed. Recently, in multicenter randomized trial, Zhang and his group investigated gemcitabine and cisplatin as induction chemotherapy (ICT) added to CRT.It showed improvement in recurrence free survival and overall survival.More importantly 96.7% of the experimental arm completed the treatment protocol. This was further confirmed by an updated network of meta analysis by Bongiovanni et al.Again the question of "when" is still valid.Our proposal is to compare tolerable regimen in induction versus adjuvant settings.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Excluded: Stage T3N0
Performance status
WHO 0–1
Prior therapy
Cannot have received: systemic chemotherapy
The patient has received prior systemic chemotherapy within the last three years.
Cannot have received: surgery
Exception: biopsy
The patient has undergone previous surgery for the tumor, other than biopsy.
Cannot have received: radiation therapy to the head or neck
The patient has received prior radiation therapy to the head or neck
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/mm; Platelet count ≥ 100,000/mm; Hemoglobin ≥ 8g/dl
Kidney function
Urea and serum creatinine ≤ 1.5 mg/dl (for cisplatin); Creatinine clearance ≥ 60 ml/min (for cisplatin)
Liver function
SGOT and SGPT ≤ 2 × upper limit of laboratory normal
Laboratory values performed within 14 days prior to concurrent chemotherapy should be as follows: i) Absolute neutrophil count (ANC) ≥ 1500/mm ii) Platelet count ≥ 100.000/mm iii) Hemoglobin ≥ 8g/dl iv) Urea and serum creatinine ≤ 1.5 mg/dl. (for cisplatin) v) Creatinine clearance ≥ 60 ml/min. (for cisplatin) vi) SGOT and SGPT ≤ 2 × upper limit of laboratory normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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