Preoperative TPF Chemotherapy in a Population of Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Docetaxel; Fluorouracil

Criteria

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