Using stathmin to predict chemotherapy outcomes in oral cancer
Official title: A Randomized Phase II Trial of Low Stathmin Expression as a Predictive Biomarker for OSCC Patients Receiving TPF Induction Chemotherapy Followed by Radical Surgery and Radiotherapy/Chemoradiotherapy
Run by Shanghai Jiao Tong University School of Medicine · NCT03326947 · Data updated 2026-11-12
This study is testing if measuring stathmin levels can help predict which patients with oral cancer will benefit more from a specific chemotherapy treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2018 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | February 20, 2024 |
| Trial ID | NCT03326947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with a diagnosis of squamous cell carcinoma of the oral cavity and low stathmin expression.
✕Probably not a fit
Patients with distant metastatic disease, previous cancer treatments, or severe systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the predictive value of stathmin expression as a biomarker in patients with oral squamous cell carcinoma (OSCC) undergoing TPF induction chemotherapy, which consists of docetaxel, cisplatin, and 5-fluorouracil. The study aims to determine if patients with low stathmin expression benefit more from this treatment compared to those with higher levels. Participants will receive the chemotherapy followed by radical surgery and postoperative radiotherapy. The trial is designed as a prospective, open-label, randomized control study to evaluate the effectiveness of this approach.
Why it matters
Potential benefit: If successful, this study could help identify which OSCC patients are more likely to benefit from TPF induction chemotherapy, potentially improving treatment outcomes.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of TPF induction chemotherapy, but this specific focus on stathmin expression is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.