Clinical trial · Interventional
Preoperative TPF Chemotherapy in Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer
Phase II Study of Preoperative TPF Chemotherapy in Locally Advanced Resectable Oral Cavity Squamous Cell Cancer in Order to Improve the Rate of Pathological Complete Response
NCT01914900CI-TRIAL-00070631completedPhase 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)
This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer. The aim is to improve the rate of pathological complete response to induction chemotherapy in a molecular enriched population, consisting of patients with tumour harbouring a functional p53 protein and/or showing low expression of beta-tubulin II.
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 |
|---|---|---|---|
| Locally Advanced Resectable Oral Cavity Squamous Cell Cancer | Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel, cisplatin, 5 fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- induction TPF chemotherapy
- description
- Each patient will receive induction CT, consisting of TPF (docetaxel 75 mg/sm and cisplatin 80 mg/sm day 1 and 5 fluorouracil 800 mg/sm each day in continuous infusion day 1-4, according to Paccagnella et al, ASCO 2008) for 3 cycles every 21 days, followed by surgery.
- interventionNames
- Drug: docetaxel, cisplatin, 5 fluorouracil
Primary outcomes (1)
- measure
- pathologic complete remission
- timeFrame
- After 9 weeks since chemotherapy start
- description
- For what concerns primary endpoint of pathologic complete remission achievement, the patients will be assessed at time of surgery, i.e., after about 9 weeks since chemotherapy start.
Secondary outcomes (6)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Males and females age \> 18 years * Histologically proved primary oral cavity squamous cell cancer (tumour extending to oropharynx are accepted if oropharyngeal invasion is \< 20% of the tumour size) * Stage T2 (T2 stage is accepted if tumour size is 3 cm or larger).-T3, N1- N3 and T4a any N * WHO performance status \< 1 * Availability of block of Formalin Fixed Paraffin Embedded (FFPE) biopsy of the tumour * Radiological imaging of the tumour with MRI pre-therapy * Effective contraception for both male and female subjects if risk of conception exists Exclusion Criteria: * Prior antitumour therapy for head \& neck cancer (chemotherapy or biological therapy and radiotherapy) * Metastatic disease * Medical condition that contraindicate administration of TPF scheme, in particular: 1. clinically significant cardiac disease including unstable angina, acute myocardial infarction in the previous 2 years, congestive heart failure and arrhythmia requiring therapy 2. chronic or current infectious disease that contraindicate administration of chemotherapy causing neutropenia; known HIV, Hepatitis B or C positivity 3. uncontrolled renal, hepatic, neurological, cerebral, psychiatric, haematological, gastrointestinal, pulmonary, vascular or endocrine diseases that could interfere with antiblastic treatment * Pre-existing peripheral neuropathy according to Common Toxicity Criteria (CTC) Adverse Event grade \> 1 * Pre-existing ototoxicity grade \> 1 * Previous diagnosis of other cancer in the last 3 years (in situ cervical cancer or completely excised basocellular/squamocellular skin cancer are always admitted ) * Previous other cancer in oral cavity to less than 2 cm from existing primary * Breast feeding women or women with a positive pregnancy test at Visit 0 or 1 * Screening laboratory values: * Neutrophils \< 1.5 x 109/L * Platelets \< 100 x 109/L * ALT or AST \> 2.5 times upper limit of normal * Calculated creatinine clearance \< 60 mL/min * Weight loss more than 20% in 3 months preceding the study * Technical unresectability defined as: T4b staging or N ulcerating the skin or encasing internal carotid
References
Publications (0)
Data not yet available
No reference posted for this study.