Clinical trial · Interventional
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
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
NCT03326947CI-TRIAL-00074113recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Neck | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel, cisplatin and 5-fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TPF group
- description
- The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed with surgery and radiotherapy/chemoradiotherapy. docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day
- interventionNames
- Drug: docetaxel, cisplatin and 5-fluorouracil
- type
- NO_INTERVENTION
- label
- Control group
- description
- The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 12 weeks.
- description
- Overall survival was calculated from the date of randomization to death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.