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

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ClinicalTrials.gov Identifier: NCT01914900
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Resectable Oral Cavity Squamous Cell Cancer Drug: docetaxel, cisplatin, 5 fluorouracil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: induction TPF chemotherapy Drug: docetaxel, cisplatin, 5 fluorouracil



Primary Outcome Measures :
  1. pathologic complete remission [ Time Frame: After 9 weeks since chemotherapy start ]
    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 Outcome Measures :
  1. Progression free survival [ Time Frame: 5 years ]
    Patients will be followed up to 5 years for what concerns PFS

  2. Overall Survival [ Time Frame: 5 years ]
    Patients will be followed up to 5 years for what concerns OS

  3. Compliance to induction chemotherapy [ Time Frame: 9 weeks ]
  4. Percentage of patient receiving postoperative radiotherapy and chemotherapy [ Time Frame: 6 months ]
  5. Early functional response evaluation by DWI and DCE MRI [ Time Frame: 3 weeks ]
    radiological evaluation after 1 cycle of induction chemotherapy

  6. Comparison between (DWI - DCE) MRI response and pathological response [ Time Frame: 9 weeks ]
    comparison between radiological assessment of response and pathological one



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914900


Locations
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Italy
Istituto Nazionale Tumori
Milano, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Responsible Party: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01914900    
Other Study ID Numbers: INT40/10
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
oral cavity cancer
induction chemotherapy
TP53
beta tubulin II
Additional relevant MeSH terms:
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Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma
Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs