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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00704639




Registration number
NCT00704639
Ethics application status
Date submitted
22/06/2008
Date registered
25/06/2008
Date last updated
12/07/2017

Titles & IDs
Public title
Chemoradiation Treatment for Head and Neck Cancer
Scientific title
A Phase II Study of Cetuximab, Carboplatin and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
TROG 07.04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Carboplatin
Treatment: Other - Radiotherapy

Experimental: Single arm - Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)


Treatment: Drugs: Cetuximab
Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy

Treatment: Drugs: Carboplatin
Weekly intravenous carboplatin (AUC 2) for the duration of the RT

Treatment: Other: Radiotherapy
The radiotherapy schedule will be the "infield boost" (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Feasibility
Timepoint [1] 0 0
An initial 6 patients will be treated. Once all these patients have a 2 week post RT review there will be analysis. If <= 1 patient has a DLT than the treatment is deemed safe.
Secondary outcome [1] 0 0
Failure free survival (FFS)
Timepoint [1] 0 0
All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Secondary outcome [2] 0 0
Time to local and/or regional failure
Timepoint [2] 0 0
All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Secondary outcome [4] 0 0
Site of first failure
Timepoint [4] 0 0
All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Secondary outcome [5] 0 0
Acute and late treatment toxicities
Timepoint [5] 0 0
All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

Eligibility
Key inclusion criteria
* Previously untreated SCC of the oropharynx, larynx or hypopharynx.
* Stage III or IV, excluding T1N1, and metastatic disease (to be confirmed by a chest CT, and abdominal CT or ultrasound scan if patients with abnormal liver function tests or a bone scan or FDG-PET if patients with bone pain).
* Histologically or cytologically confirmed HNSCC
* Disease must be considered potentially curable by chemoradiation
* Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:

* Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
* Severe tinnitus
* Renal impairment (GFR < 60ml/min)
* Peripheral neuropathy > grade 2
* Inability to tolerate intravenous hydration eg due to cardiac disease
* Co-morbidities (based on clinical judgement by the investigator) associated with ECOG PS 2 that in the view of the investigator would preclude the safe administration of cisplatin
* Performance status ECOG 0, 1 or 2.
* Adequate haematological, renal and hepatic functions as defined by:

* Absolute neutrophil count (ANC, segmented cells (segs) + bands)>= 1.5 x 109/L
* Platelet count >= 100 x 109/L
* Total bilirubin <= 1.5 x upper normal limit
* Alanine aminotransferase <= 2.5 x upper normal limit
* Calculated creatinine clearance > 40ml/min (Cockcroft-Gault formula).
* If calculated creatinine clearance < 50 ml/min, glomerular filtration rate to be measured with DTPA or EDTA scan. If < 40 ml/min not eligible.
* Age >18 years
* Signed written consent
* Suitable for follow-up for 4 years in the view of the investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Distant metastases, i.e., any metastatic disease below the clavicles. Patients with lung nodules >10mm will be excluded unless non-malignancy aetiology is established. Patients with lesions 5-10mm can be included if a FDG-PET scan is negative and the investigator considers on clinical grounds that metastasis is unlikely. Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
* Previous radical RT to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
* Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
* Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as HIV infection, cardiac failure, pulmonary compromise, active infection
* Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
* Pregnant or lactating women.
* Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
* High risk for poor compliance with therapy or follow up as assessed by the investigator
* Prior radiation to greater than 30% of the bone marrow
* Prior systemic chemotherapy for cancer
* Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
* Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.

The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.
Trial website
https://clinicaltrials.gov/study/NCT00704639
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
June Corry
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00704639