NCT00193895|CompletedPhase 3
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Sponsor study identifier
interventional
321
2 countries
21
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
March 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)March 2016
Actual (reported)March 31, 2016
Actual (reported)Loco-regional Control
The date of primary outcome analysis will occur when the final patient has reached a minimum 2 years follow-up.
Disease Free Survival
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Overall Survival
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Quality of Life
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Treatment-related Late Effects
The date of analysis will occur when the final patient has reached a minimum 2 years follow-up.
Radiotherapy alone (60Gy or 66Gy in 30-33 fractions 5-5/week)
Radiotherapy plus chemotherapy (Radiotherapy 60Gy or 66Gy in 30-33 fractions 5/week + Carboplatin (AUC 2) intravenously weekly)
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.
60 Gy OR 66Gy in 2Gy/fraction 5days/week
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Riverina Cancer Centre
Wagga Wagga, New South Wales, 2650, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Illawarra Cancer Care Centre
Wollongong, New South Wales, 2500, Australia
Porceddu SV, Connolly E, Bressel M, Wratten C, Liu HY, Rischin D. Prognostic Subgroups for Disease-Free Survival With Cutaneous Squamous Cell Carcinoma of the Head and Neck: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Oct 1;151(10):938-945. doi: 10.1001/jamaoto.2025.2110.
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.
Sandro Porceddu
Princess Alexandra Hospital
321 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study to Determine if Tissue Scored With a Scalpel Results in Any Noticeable Marks
Contact the study team to confirm eligibility.
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Mater QRI
South Brisbane, Queensland, 4101, Australia
St Andrew's Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
North Queensland Oncology Service
Townsville, Queensland, 4810, Australia
Genesis Cancer Care (previously Premion)
Tugun, Queensland, 4224, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
William Buckland Radiotherapy Centre, The Alfred
Melbourne, Victoria, 3004, Australia
Auckland Hospital
Auckland, 1001, New Zealand
Christchurch Hospital
Christchurch, 4710, New Zealand
Waikato Hospital
Hamilton, 3200, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Primary Completion
March 2016
Actual (reported)Study Completion
March 31, 2016
Actual (reported)Last Updated
April 6, 2018
Record last verified: 2018-04
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