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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00193895
Registration number
NCT00193895
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
6/04/2018
Titles & IDs
Public title
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck
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Scientific title
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy in High-risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
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Secondary ID [1]
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TROG 05.01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Skin Cancer
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Other - Radiotherapy
Active Comparator: Radiotherapy alone - Radiotherapy alone (60Gy or 66Gy in 30-33 fractions 5-5/week)
Experimental: Radiotherapy plus chemotherapy - Radiotherapy plus chemotherapy (Radiotherapy 60Gy or 66Gy in 30-33 fractions 5/week + Carboplatin (AUC 2) intravenously weekly)
Treatment: Drugs: Carboplatin
Carboplatin will commence with a dose calculated to target an AUC of 2.0. A maximum of 6 doses of weekly Carboplatin will be given. Carboplatin will be administered intravenously over 20-30 minutes prior to radiation therapy.
Treatment: Other: Radiotherapy
60 Gy OR 66Gy in 2Gy/fraction 5days/week
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Loco-regional Control
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Assessment method [1]
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Timepoint [1]
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The date of primary outcome analysis will occur when the final patient has reached a minimum 2 years follow-up.
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Secondary outcome [1]
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Disease Free Survival
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Assessment method [1]
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Timepoint [1]
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The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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Timepoint [2]
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The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
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Secondary outcome [3]
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Quality of Life
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Assessment method [3]
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Timepoint [3]
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The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
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Secondary outcome [4]
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Treatment-related Late Effects
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Assessment method [4]
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Timepoint [4]
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The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
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Eligibility
Key inclusion criteria
- Histologically proven SCC
- Patients have undergone either:
- Resection of the primary lesion
- Any type of parotidectomy (superficial, total, partial, etc.)
- Any type of neck dissection(s)
- High risk feature(s); Advanced primary disease or high risk nodal disease
High Risk Nodal Disease
- Intra-parotid nodal disease (any number or size, with/without extracapsular extension,
with/without an identifiable index lesion)
- Cervical nodal disease with a synchronous index lesion or previously resected
cutaneous primary tumour (<5 years) within the corresponding nodal drainage and a
mucosal primary has been excluded with at least a CT +/- MRI and panendoscopy* *For
cervical nodal disease to be eligible there must be at least one of the following
criteria:
- > 2 nodes
- largest node > 3 cm
- Extracapsular extension
Advanced Primary Disease (TNM 6th Edition 2002) (Appendix 1)
- T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, > 4 cm) of the
head and neck including lip, nose and external auditory canal with or without nodal
disease
- In transit metastases (metastases between the primary site and the adjoining nodal
basin)
- Age > 18 years
- Written informed consent
- ECOG <= 2
- Absolute neutrophil count > 1.5 X 10^9/L, platelet count > 100 X 10^9/L, and
haemoglobin > 10 g/dL (pre-radiotherapy blood transfusion to elevate the
haemoglobin > 10 g/dL is permissible)
- Calculated creatinine clearance (Cockcroft-Gault) >= 40 mL/min
- Available for follow-up for up to 5 years
- Life expectancy greater than 6 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Intercurrent illness that will interfere with either the chemotherapy or radiotherapy
such as immunosuppression due to medication or medical condition
- Metastasis(es) below the clavicles
- Previous radical radiotherapy to the head and neck, excluding treatment of an early
glottic cancer greater than or equal to 2 years ago and superficial radiotherapy to
cutaneous SCC or Basal cell carcinoma
- High risk for poor compliance with therapy or follow-up as assessed by investigator
- Pregnant or lactating women
- 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 Level 1 cutaneous melanomas or early glottic cancer > 2 years
ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix.
- Low risk cervical nodal disease* without advanced primary disease
*Low risk cervical nodal disease is defined as the presence of all of the following
criteria:
- single nodal metastasis
- greater then or equal to 3cm,
- no extracapsular extension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2016
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Sample size
Target
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Accrual to date
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Final
321
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Calvary Mater Newcastle - Newcastle
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [5]
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Riverina Cancer Centre - Wagga Wagga
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Recruitment hospital [6]
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Westmead Hospital - Wentworthville
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Recruitment hospital [7]
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Illawarra Cancer Care Centre - Wollongong
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Recruitment hospital [8]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [9]
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Royal Brisbane Hospital - Herston
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Recruitment hospital [10]
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Mater QRI - South Brisbane
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Recruitment hospital [11]
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St Andrew's Toowoomba Hospital - Toowoomba
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Recruitment hospital [12]
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North Queensland Oncology Service - Townsville
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Recruitment hospital [13]
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Genesis Cancer Care (previously Premion) - Tugun
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Recruitment hospital [14]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [15]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [16]
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Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
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Recruitment hospital [17]
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William Buckland Radiotherapy Centre, The Alfred - Melbourne
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Recruitment postcode(s) [1]
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1871 - Liverpool
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Recruitment postcode(s) [2]
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2298 - Newcastle
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2050 - Sydney
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Recruitment postcode(s) [5]
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2650 - Wagga Wagga
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Recruitment postcode(s) [6]
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2145 - Wentworthville
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Recruitment postcode(s) [7]
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2500 - Wollongong
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Recruitment postcode(s) [8]
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4102 - Brisbane
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Recruitment postcode(s) [9]
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4029 - Herston
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Recruitment postcode(s) [10]
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4101 - South Brisbane
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Recruitment postcode(s) [11]
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4350 - Toowoomba
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Recruitment postcode(s) [12]
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4810 - Townsville
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Recruitment postcode(s) [13]
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4224 - Tugun
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Recruitment postcode(s) [14]
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5000 - Adelaide
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Recruitment postcode(s) [15]
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3002 - East Melbourne
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Recruitment postcode(s) [16]
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3220 - Geelong
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Recruitment postcode(s) [17]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Hamilton
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Country [4]
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New Zealand
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State/province [4]
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Palmerston North
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Royal Australian and New Zealand College of Radiologists
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the trial is to determine, in patients who have undergone surgery
with curative intent for high-risk CSCC of the head and neck, whether there is a difference
in time to loco-regional relapse between patients treated with post-operative concurrent
chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The
target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on
an anticipated accrual of 80 patients/year. A further 2 years follow up is required.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00193895
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sandro Porceddu
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Address
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Princess Alexandra Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00193895
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