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 - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021658-21-IT

Enrollment

Registered

2010-08-26

Start date

2010-09-27

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral cavity cancer

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent - Males and females age > 18 years - Hystologically proved primary oral cavity squamous cell cancer (tumour extending to oropharynx are accepted if oropharyngeal invasion is =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Prior antitumor therapy for head & neck cancer (chemotherapy or biological therapy and radiotherapy) - Metastatic disease - Medical condition that contraindicate administration of TPF scheme, in particular: a) clinically significant cardiac disease including unstable angina, acute myocardial infarction in the previous 2 years, congestive heart failure and arrhythmia requiring therapy b) chronic or current infectious disease that contraindicate administration of chemotherapy causing neutropenia; known HIV, Hepatitis B or C positivity c) uncontrolled renal, hepatic, neurological, cerebral, psychiatric, haematological, gastrointestinal, pulmonary, vascular or endocrine diseases that could interfere with antiblastic treatment - Pre-existing peripheral neurophaty CTC 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 2.5 times upper limit of normal • Calculated creatinine clearance < 60 mL/min according to Cockroft-Gault formula • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: pCR percentage after CT;Secondary Objective: PFS, OS, response rate and toxicity;Primary end point(s): pCR percentage	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026