Clinical trial · Interventional
Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage
Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial
NCT02290145CI-TRIAL-00071598recruitingPhase 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)
The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative radiotherapy | Radiation | — | UNRESOLVED |
| surgery group | Procedure | — | UNRESOLVED |
| TPF group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TPF group
- description
- TPF induction chemotherapy followed with surgery and post-operative radiotherapy docetaxel 75mg/m2 cisplatin 75 mg/m2 5-Fu 750 mg/m2/day
- interventionNames
- Drug: TPF group
- Procedure: surgery group
- Radiation: Post-operative radiotherapy
- type
- OTHER
- label
- surgery group
- description
- surgery with post-operative radiotherapy
- interventionNames
- Procedure: surgery group
- Radiation: Post-operative radiotherapy
Primary outcomes (1)
- measure
- overall survival rate as a measure by the numbers of living patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 75 years old. * Sex: both males and females. * Karnofsky performance status (KPS) \>60. * Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region). * Cyclin D1 high expression * Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[International Union Against Cancer\] 2002) with resectable lesions. * Adequate hematologic function: 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. * Renal function: serum creatinine \<1.5 times ULN. * Written informed consent Exclusion Criteria: * Evidence of distant metastatic disease and other cancers. * Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy). * Previous radiotherapy or chemotherapy. * Other previous malignancies within 5 years. * Can not tolerate the treatment protocol with systematic diseases such as history of 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.