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Locally Advanced Resectable Oral Cavity Squamous Cell CancerPhase 2NCT01914900

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

A Phase 2 study testing docetaxel, cisplatin, 5 fluorouracil in people with Locally Advanced Resectable Oral Cavity Squamous Cell Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
docetaxel, cisplatin, 5 fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteItaly
Study dates
Jun 2012to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Nazionale Tumori

    Milan, 20133

Other trials in Italy

About this study

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

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.

Read the 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 study and in order to analyze the tumour biopsy. If a functional p53 protein status and/or low expression of beta-tubulin II is identified, patient will be enrolled in therapeutic part of the study. In case of different molecular profile, patient will not be enrolled in the study. A radiological work up of disease is required before to start CT. A magnetic resonance imaging (MRI) with DWI, and if available, a dynamic contrast enhanced (DCE)-MRI will be performed before therapy.

Each patient will receive induction CT, consisting of TPF (docetaxel 75 mg/sm and cisplatin 80 mg/sm day 1 and 5 fluorouracil 800 mg/sm each day in continuous infusion day 1-4, according to Paccagnella et al, ASCO 2008) for 3 cycles every 21 days, followed by surgery. Prophylactic antibiotic with ciprofloxacin 500 mg 2 times/day will be administered starting from day 5th to day 15th after each cycle; G-CSF is admitted as secondary prophylaxis in case of febrile neutropenia or neutropenia grade 4 at previous cycle. Patient will have clinical examination at baseline and before each CT cycle. Whenever a clinical suspicion of progressing disease will exist, a radiological restaging with MRI will be performed and in case of radiological progression according to RECIST 1.1 the patient will be submitted to surgical excision of the tumour. However, in any case the investigators may 14 judge that the disease is progressing and they consider that chemotherapy is no more indicated, the patient will be submitted to surgery even without a radiological confirmation of progression. In case of clinical SD or PR, a radiological restaging will be planned with MRI and DWI-MRI at least two weeks after the third cycle (a DWI- MRI and, if available a DCE-MRI, will be performed after 1st cycle in order to evaluate early response imaging). Surgery will be performed within one month after the last cycle of CT, if there are no clinical contraindications. After the surgical treatment, adjuvant treatment will be delivered according to recognized pathological risk factors (Bernier J, 2005). Patients will be followed up according to the Institutional follow-up policy.

Being tested
docetaxel, cisplatin, 5 fluorouracil
Keywords
oral cavity cancer, induction chemotherapy, TP53, beta tubulin II
Medical subject headings
Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxel, cisplatin, 5 fluorouracilDrug

    Also called taxotere, cisplatin, tolerak

Study groups in NCT01914900
Study groupRoleWhat they receive
induction TPF chemotherapyExperimentalEach patient will receive induction CT, consisting of TPF (docetaxel 75 mg/sm and cisplatin 80 mg/sm day 1 and 5 fluorouracil 800 mg/sm each day in continuous infusion day 1-4, according to Paccagnella et al, ASCO 2008) for 3 cycles every 21 days, followed by surgery.
Receives: Drug: docetaxel, cisplatin, 5 fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathologic complete remission

    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.

    Measured: After 9 weeks since chemotherapy start

Secondary outcomes (6)

  1. Progression free survival

    Patients will be followed up to 5 years for what concerns PFS

    Measured: 5 years

  2. Overall Survival

    Patients will be followed up to 5 years for what concerns OS

    Measured: 5 years

  3. Compliance to induction chemotherapy

    Evaluation in terms of the number of cycles administered, actual and total doses dministered, dose modifications, delays and omissions, as well as reasons for deviation from planned therapy and overall treatment duration will be described

    Measured: 9 weeks

  4. Percentage of patient receiving postoperative radiotherapy and chemotherapy

    Patients will be followed for what concerns PFS, defined as the time from the date of randomization up to the date of first progression, second primary malignancy or death from any cause, whichever comes first.

    Measured: 6 months

  5. Early functional response evaluation by DWI and DCE MRI

    radiological evaluation after 1 cycle of induction chemotherapy

    Measured: 3 weeks

  6. Comparison between (DWI - DCE) MRI response and pathological response

    comparison between radiological assessment of response and pathological one

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01914900
Sponsor's protocol ID
INT40/10
Status last verified
Oct 2023
First submitted
29 Jul 2013
Last updated
19 Oct 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel, cisplatin, 5 fluorouracil in people with Locally Advanced Resectable Oral Cavity Squamous Cell Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic complete remission (time frame: After 9 weeks since chemotherapy start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01914900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

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