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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
Scientific title
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy in High-risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Secondary ID [1] 0 0
TROG 05.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
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
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
Loco-regional Control
Timepoint [1] 0 0
The date of primary outcome analysis will occur when the final patient has reached a minimum 2 years follow-up.
Secondary outcome [1] 0 0
Disease Free Survival
Timepoint [1] 0 0
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Secondary outcome [3] 0 0
Quality of Life
Timepoint [3] 0 0
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Secondary outcome [4] 0 0
Treatment-related Late Effects
Timepoint [4] 0 0
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Riverina Cancer Centre - Wagga Wagga
Recruitment hospital [6] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [7] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [9] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [10] 0 0
Mater QRI - South Brisbane
Recruitment hospital [11] 0 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [12] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [13] 0 0
Genesis Cancer Care (previously Premion) - Tugun
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [16] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
William Buckland Radiotherapy Centre, The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [6] 0 0
2145 - Wentworthville
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4102 - Brisbane
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4350 - Toowoomba
Recruitment postcode(s) [12] 0 0
4810 - Townsville
Recruitment postcode(s) [13] 0 0
4224 - Tugun
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
3002 - East Melbourne
Recruitment postcode(s) [16] 0 0
3220 - Geelong
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Palmerston North

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Royal Australian and New Zealand College of Radiologists
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00193895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandro Porceddu
Address 0 0
Princess Alexandra Hospital
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