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Trial registered on ANZCTR


Registration number
ACTRN12609000642280
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
30/07/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Taxotere, Cisplatin and 5-Fluorouracil (TPF) induction chemotherapy on intratumoral hypoxia in advanced head and neck squamous cell cancer
Scientific title
A pilot study evaluating the impact of Taxotere, Cisplatin and 5-Fluorouracil (TPF) induction chemotherapy on intratumoral hypoxia in locoregionally advanced head and neck squamous cell cancer
Secondary ID [1] 933 0
secondary ID: HNHXTPF
issuing authority: Centre for Biostatistics & Clinical Trials - Peter MacCallum Cancer Centre
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced head and neck squamous cell cancer 237290 0
Condition category
Condition code
Cancer 239616 239616 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-Taxotere, 75mg/m2 intravenous (IV) over 1 hour on day 1 of each cycle of TPF
-Cisplatin, 100mg/m2 Intravenous (IV) immediately after Taxotere on day 1 of each cycle of TPF
-5-Fluorouracil, 1000mg/m2 continuous infusion on days 1-4 of each cycle of TPF
- TPF chemotherapy will be given every 3 weeks for a total of 3 cycles
chemoradiation will comprise of radiation 70 Gy radiation in 35 Gy fractions given daily 5 days a week for 7 weeks.
cisplatin and 5-Fluorouracil will be administered in weeks 1,4 & 7 of radiation only
Intervention code [1] 236967 0
Treatment: Drugs
Intervention code [2] 236968 0
Other interventions
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238402 0
To test the hypothesis that induction chemotherapy with TPF abrogates intratumoural hypoxia (detected by fluoroazomycin-arabinoside (FAZA) Positron Emission Tomography (PET)imaging prior to chemoradiation
Timepoint [1] 238402 0
FAZA uptake at baseline and after 3 cycles of TPF
Secondary outcome [1] 244873 0
To determine the response rates to TPF in hypoxic and non-hypoxic sites of disease and to correlate hypoxia with response to chemoradiation
Timepoint [1] 244873 0
- comparison of tumour measurements (by Computerised Tomography (CT) prior to and after 3 cycles of TPF

- correlation of FAZA uptake at baseline and after TPF with response as assessed by FDG PET at completion of chemoradiation

Eligibility
Key inclusion criteria
- Aged 18 years or older
- previously untreated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- Histologically or cytologically confirmed squamous cell carcinoma
- stage 3 or 4 disease
- adequate hematological, renal, hepatic and pulmonary function
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- creatinine clearance > or = 60ml/min
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- women who are pregnant or lactating
- previous radiotherapy to area to be treated
- prior diagnosis of cancer
- clinical evidence of metastatic disease
- pre existing motor or sensory neurotoxicity or neuropathy > or = grade 1
- clinically significant sensorineural hearing loss
- active uncontrolled infection
- unstable cardiac disease requirin treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling a patient involves obtaining signatures on the patient information and consent form, checking the eligibility criteria, completing all baseline assessments and faxin the completed request for registration form to the clinical trial manager for processing, the trial participant will then be allocated a trial number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237353 0
Commercial sector/Industry
Name [1] 237353 0
Sanofi Aventis
Address [1] 237353 0
Talavera Corporate Centre
Building D
12-24 Talavera Road
Macquarie Park, NSW 2113
Country [1] 237353 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne, Vic 3002
Country
Australia
Secondary sponsor category [1] 236845 0
None
Name [1] 236845 0
Address [1] 236845 0
Country [1] 236845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239481 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 239481 0
St Andrews Place, East Melbourne, Victoria 3002
Ethics committee country [1] 239481 0
Australia
Date submitted for ethics approval [1] 239481 0
20/07/2009
Approval date [1] 239481 0
29/10/2009
Ethics approval number [1] 239481 0
09/43

Summary
Brief summary
This study looks at the impact of TPF chemotherapy (combined Taxotere, Cisplatin and 5-Fluorouracil) on squamous cell (skin) cancer of the head and neck as measured by the oxygen levels in the tumour.

Who is it for?
You can join this study if you have locally advanced or locally recurring squamous cell carcinoma of the oral cavity or laryngeal region, which has not been previously treated.

Trial details
Participants will all receive treatment with TPF (combined Taxotere, Cisplatin and 5-Fluorouracil) chemotherapy followed by chemoradiation which is the standard treatment for locally advanced or locally recurrent head and neck cancer. The study aims to test whether chemotherapy with TPF gets rid of low oxygen levels in tumours as detected by FAZA PET imaging uptake (a way to measure oxygen levels in the tumour) prior to chemoradiation. FAZA uptake is measured prior to treatment and again after 3 cycles of TPF. The response rate to chemotherapy will also be assessed with a CT scan before and after chemotherapy and the response to chemoradiation will be determined by a FDG PET scan at the completion of treatment. The response to treatment will be correlated with the level of hypoxia in the tumour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29924 0
Address 29924 0
Country 29924 0
Phone 29924 0
Fax 29924 0
Email 29924 0
Contact person for public queries
Name 13171 0
poppy Kypreos
Address 13171 0
Centre for Biostatistics & Clinical Trials
Peter MacCallum Cancer Centre
Level 2, 10 St Andrews Place
East Melbourne
Vic 3002
Country 13171 0
Australia
Phone 13171 0
+61 3 9656 1268
Fax 13171 0
+61 3 9656 1420
Email 13171 0
poppy.kypreos@petermac.org
Contact person for scientific queries
Name 4099 0
Dr Ben Solomon
Address 4099 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Vic 3002
Country 4099 0
Australia
Phone 4099 0
+61 3 9656 1697
Fax 4099 0
Email 4099 0
ben.solomon@petermac.org

No information has been provided regarding IPD availability
Summary results
No Results