Status:
RECRUITING
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Neoplasm Neck
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 b...
Detailed Description
Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03326947
Start Date
January 1 2018
End Date
January 1 2027
Last Update
February 20 2024
Active Locations (1)
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1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011