Status:
COMPLETED
Preoperative TPF Chemotherapy in Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Locally Advanced Resectable Oral Cavity Squamous Cell Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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...
Detailed Description
Patients with stage T2 (\> 3 cm) T3 N1-N3 and T4a any N primary OCSCC are considered for enrolment in this trial. Patients will be asked to sign the informed consent for being admitted to the clinical...
Eligibility Criteria
Inclusion
- 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
- 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:
- clinically significant cardiac disease including unstable angina, acute myocardial infarction in the previous 2 years, congestive heart failure and arrhythmia requiring therapy
- chronic or current infectious disease that contraindicate administration of chemotherapy causing neutropenia; known HIV, Hepatitis B or C positivity
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01914900
Start Date
June 1 2012
End Date
March 1 2015
Last Update
October 19 2023
Active Locations (1)
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1
Istituto Nazionale Tumori
Milan, Italy, 20133