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Trial registered on ANZCTR


Registration number
ACTRN12613000695707
Ethics application status
Approved
Date submitted
10/06/2010
Date registered
25/06/2013
Date last updated
16/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chemoradiation Treatment for Head and Neck Cancer
Scientific title
TROG 07.04 A Phase I/II Study of Cetuximab, Carboplatin and Radiotherapy for patients with locally advanced head and neck squamous cell carcinoma
Secondary ID [1] 251986 0
ClinicalTrials.gov ID NCT00704639
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Head and Neck Squamous Cell Carcinoma 257551 0
Condition category
Condition code
Cancer 257712 257712 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. 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
2. Carboplatin. Weekly intravenous carboplatin (Area Under the Curve (AUC) 2) for the duration of the radiotherapy
3. 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 - 5fractions/ week - for a specific subgroup of patients where IFB is not recommended).
Intervention code [1] 256640 0
Treatment: Drugs
Intervention code [2] 256641 0
Treatment: Other
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258610 0
Safety and Feasibility. Measured as satisfactory completion of the protocol treatment regimen
Timepoint [1] 258610 0
An initial 6 patients will be treated. Once all these patients have a 2 week post radiotherapy review there will be analysis. If <= 1 patient has a Dose Limiting Toxicity (DLT) than the treatment is deemed safe.
Secondary outcome [1] 264519 0
Failure Free Survival. Defined as the time from registration to the first failure of any type (local, regional or distant) or death from any cause. Failure will be confirmed via Fine Needle Aspiration (FNA) cytology or biopsy as well as Computed Tomogrphy (CT) image of area of interest.
Timepoint [1] 264519 0
All patients will be followed until the last patient enrolled has a minimum follow-up of 2 years post treatment. Patients will be assessed at baseline, then at 2, 4, 8, 12 and 24 weeks then 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, and 48 months post treatment.
Secondary outcome [2] 264520 0
Time to Local and/or regional failure. Failure will be confirmed via Fine Needle Aspiration (FNA) cytology or biopsy as well as Computed Tomogrphy (CT) image of area of interest.
Timepoint [2] 264520 0
All patients will be followed until the last patient enrolled has a minimum follow-up of 2 years post treatment. Patients will be assessed at baseline, then at 2, 4, 8, 12 and 24 weeks then 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, and 48 months post treatment.
Secondary outcome [3] 264521 0
Overall Survival Time. Defined from point of registration to death from any cause.
Timepoint [3] 264521 0
All patients will be followed until the last patient enrolled has a minimum follow-up of 2 years post treatment. Patients will be assessed at baseline, then at 2, 4, 8, 12 and 24 weeks then 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, and 48 months post treatment.
Secondary outcome [4] 264522 0
Site of first Failure. Failure will be confirmed via Fine Needle Aspiration (FNA) cytology or biopsy as well as Computed Tomogrphy (CT) image of area of interest.
Timepoint [4] 264522 0
All patients will be followed until the last patient enrolled has a minimum follow-up of 2 years post treatment. Patients will be assessed at baseline, then at 2, 4, 8, 12 and 24 weeks then 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, and 48 months post treatment.
Secondary outcome [5] 264523 0
Acute and Late Treatment toxicities. Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
Timepoint [5] 264523 0
All patients will be followed until the last patient enrolled has a minimum follow-up of 2 years post treatment. Patients will be assessed at baseline, weekly during treatment, then at 2, 4, 8, 12 and 24 weeks then 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, and 48 months post treatment.

Eligibility
Key inclusion criteria
1. Previously untreated Squamous Cell Carcinoma (SCC) of the oropharynx, larynx or hypopharynx.
2. 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 Flurodeoxyglucose Positron Emission Tomography (FDG-PET) if patients with bone pain).
3. Histologically or cytologically confirmed Head and Neck SCC
4. Disease must be considered potentially curable by chemoradiation
5. 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 (Glomerular Filtration Rate (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 Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2 that in the view of the investigator would preclude the safe administration of cisplatin
6. Performance status ECOG 0, 1 or 2.
7. Adequate haematological, renal and hepatic functions as defined by:
- Absolute neutrophil count (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 Diethylene triamine pentaacetic acid (DTPA) or Ethylenediaminetetraacetic acid (EDTA) scan. If < 40 ml/min not eligible.
8. Age >18 years
9. Signed written consent
10. 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
1. 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 flurodeoxyglucose positron emission tomography (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.
2. Previous radical radiotherapy (RT) to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
3. 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.
4. Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as Humman Immunodeficiency virus (HIV) infection, cardiac failure, pulmonary compromise, active infection
5. Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
6. Pregnant or lactating women.
7. Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
8. High risk for poor compliance with therapy or follow up as assessed by the investigator
9. Prior radiation to greater than 30% of the bone marrow
10. Prior systemic chemotherapy for cancer
11. Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
12. 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It is recommended that all potential/eligible patients be notified to the local data manager and to the Trial Coordinating Centre. Registration of eligible patients will be delayed until 2 weeks prior to commencement of radiotherapy (and one week prior to commencement of cetuximab). This two stage procedure will reduce the risk of patients being registered but never commencing treatment (but nevertheless needing to be included in analysis). To register a patient, check the eligibility criteria have been satisfied and complete the registration form.
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 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2008
Actual
30/04/2008
Date of last participant enrolment
Anticipated
Actual
19/11/2012
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 5161 0
New Zealand
State/province [1] 5161 0
Auckland

Funding & Sponsors
Funding source category [1] 257122 0
Commercial sector/Industry
Name [1] 257122 0
Merck Onc.
Country [1] 257122 0
Germany
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group
Address
Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 Hunter Region Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 256384 0
None
Name [1] 256384 0
Address [1] 256384 0
Country [1] 256384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259166 0
Peter MacCallum Ethics Committee
Ethics committee address [1] 259166 0
Ethics committee country [1] 259166 0
Australia
Date submitted for ethics approval [1] 259166 0
Approval date [1] 259166 0
02/01/2008
Ethics approval number [1] 259166 0
07/48

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31279 0
A/Prof June Corry
Address 31279 0
Peter MacCallum Cancer Center
1 St Andrews Place
East Melbourne, Victoria, 3002
Country 31279 0
Australia
Phone 31279 0
+61 3 9656 1111
Fax 31279 0
Email 31279 0
June.Corry@petermac.org
Contact person for public queries
Name 14526 0
Christopher Griffiths
Address 14526 0
Centre for Biostatistics and Clinical Trials (BaCT)
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
VIC 3002
Country 14526 0
Australia
Phone 14526 0
+61 3 96565829
Fax 14526 0
Email 14526 0
christopher.griffiths@petermac.org
Contact person for scientific queries
Name 5454 0
Christopher Griffiths
Address 5454 0
Centre for Biostatistics and Clinical Trials (BaCT)
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
VIC 3002
Country 5454 0
Australia
Phone 5454 0
+61 3 965658289
Fax 5454 0
Email 5454 0
christopher.griffths@petermac.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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