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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

Pathological diagnosis of squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).

Age: 18 to 75 years old. Sex: both males and females. Karnofsky performance status (KPS) >70. Low grade of Stathmin 1 expression by immunohistochemistry. Clinical stage III/IVA. White blood cell >3,000/mm3, hemoglobin>8g/L, platelet count>80,000/mm3. Hepatic function: ALAT(alanine aminotransferase )/ASAT(aspartate transaminase ) <2.5 times the upper limit of normal (ULN), bilirubin <1.5 times ULN.

Serum creatinine <1.5 times ULN. Written informed consent

Exclusion Criteria:

Distant metastatic disease and other cancers. Previous surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).

Previous radiotherapy or chemotherapy. Other previous malignancies within 5 years. Sever systematic diseases such as severe pulmonary or cardiac diseases. Legal incapacity or limited legal capacity. Creatinine clearance <30ml/min. Pregnancy (confirmed by serum or urine β-HCG) or lactation period