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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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/study/NCT00193895
Trial related presentations / publications
Porceddu SV, Bressel M, Poulsen MG, Stoneley A, Veness MJ, Kenny LM, Wratten C, Corry J, Cooper S, Fogarty GB, Collins M, Collins MK, Macann AMJ, Milross CG, Penniment MG, Liu HY, King MT, Panizza BJ, Rischin D. Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial. J Clin Oncol. 2018 May 1;36(13):1275-1283. doi: 10.1200/JCO.2017.77.0941. Epub 2018 Mar 14.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00193895