Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC (NCT03326947) | Clinical Trial Compass
RecruitingPhase 2
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
China60 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Overall survival
Timeframe: 12 weeks.
Trial details
NCT IDNCT03326947
SponsorShanghai Jiao Tong University School of Medicine