Using stathmin to predict chemotherapy outcomes in oral cancer
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03326947 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with distant metastatic disease, previous cancer treatments, or severe systemic diseases may not benefit from this study.
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 performed: Previous studies have shown mixed results regarding the effectiveness of TPF induction chemotherapy, but this specific focus on stathmin expression is novel.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.