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

• Conditions: oral cavity cancer

• Registration Number: EUCTR2010-021658-21-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-26
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 < 1.5 x 109/L
•Platelets < 100 x 109/L
•GOT or GPT > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified