Actively Recruiting
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-02-20
60
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
- Age between 18 and 75 years old
- Male or female
- Karnofsky performance status greater than 70
- Low stathmin 1 expression by immunohistochemistry
- Clinical stage III or IVA
- White blood cell count greater than 3,000/mm3
- Hemoglobin level greater than 8 g/L
- Platelet count greater than 80,000/mm3
- Alanine aminotransferase and aspartate transaminase less than 2.5 times the upper limit of normal
- Bilirubin less than 1.5 times the upper limit of normal
- Serum creatinine less than 1.5 times the upper limit of normal
- Written informed consent
You will not qualify if you...
- Presence of distant metastatic disease or other cancers
- Previous surgery on the primary tumors or lymph nodes (except diagnostic biopsy)
- Previous radiotherapy or chemotherapy
- Other malignancies within the last 5 years
- Severe pulmonary or cardiac diseases
- Legal incapacity or limited legal capacity
- Creatinine clearance less than 30 ml/min
- Pregnancy or lactation confirmed by serum or urine β-HCG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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