Clinical trial · Interventional
A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients
A Randomized Phase II Trial of TPF Induction Chemotherapy in cN2 Patients With Oral Squamous Cell Carcinoma
NCT02285543CI-TRIAL-00071588terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No new participants could be enrolled.
Summary
Brief summary (as posted)
To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared to the standard treatment.
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 |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| TPF induction chemotherapy | 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: TPF induction chemotherapy
- Procedure: surgery
- Radiation: radiotherapy
- type
- OTHER
- label
- Control group
- description
- The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.
- interventionNames
- Procedure: surgery
- Radiation: radiotherapy
Primary outcomes (1)
- measure
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). * 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.