OncoMatch/Clinical Trials/NCT03326947

Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC

Is NCT03326947 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies docetaxel, cisplatin and 5-fluorouracil for neoplasm neck.

Phase 2RecruitingShanghai Jiao Tong University School of MedicineNCT03326947Data as of May 2026

Treatment: docetaxel, cisplatin and 5-fluorouracil — To investigate the predictive value of stathmin expression as a predictive biomarker in OSCC patients, who treated with TPF (docetaxel, cisplatin and 5-fluorouracil ) induction chemotherapy followed by radical surgery and radiotherapy/chemoradiotherapy.

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Extracted eligibility criteria

Biomarker criteria

Required: STMN1 low expression (low)

Disease stage

Required: Stage III, IVA

Clinical stage III/IVA

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: surgery

Exception: diagnostic biopsy

Previous surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy)

Cannot have received: radiation therapy

Previous radiotherapy

Cannot have received: cytotoxic chemotherapy

Previous chemotherapy

Lab requirements

Blood counts

White blood cell >3,000/mm3, hemoglobin >8g/L, platelet count >80,000/mm3

Kidney function

Serum creatinine <1.5x ULN; creatinine clearance <30ml/min [excluded]

Liver function

ALAT/ASAT <2.5x ULN, bilirubin <1.5x ULN

White blood cell >3,000/mm3, hemoglobin>8g/L, platelet count>80,000/mm3. Hepatic function: ALAT/ASAT <2.5x ULN, bilirubin <1.5x ULN. Serum creatinine <1.5x ULN. Creatinine clearance <30ml/min [excluded].

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

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