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

Recruiting now · Phase 2

Conditions studied: Neoplasm Neck

In brief

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.

Key facts

Study ID

NCT03326947

Run by

Shanghai Jiao Tong University School of Medicine

People needed

60

Starts

2018-01-01

Expected to finish

2027-01-01

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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