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Sponsors and Collaborators: |
Trans-Tasman Radiation Oncology Group (TROG) Princess Alexandra Hospital, Brisbane, Australia The Royal Australian and New Zealand College of Radiologists Cancer Collaborative Group |
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Information provided by: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00193895 |
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.
Condition | Intervention | Phase |
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Skin Cancer |
Drug: Carboplatin Radiation: Radiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Post-Operative Concurrent Chemo-Radiotherapy Versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 265 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Radiotherapy alone
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Radiation: Radiotherapy
60 Gy OR 66Gy in 2Gy/fraction 5days/week
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2: Experimental
Radiotherapy plus chemotherapy
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Drug: 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.
Radiation: Radiotherapy
60 Gy OR 66Gy in 2Gy/fraction 5days/week
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Two in every 3 Australians will be affected by skin cancer over their lifetime. The prevalence of skin cancer will continue to increase due to the ageing population and represents a significant problem in our community. Cure of early (T1-2) de novo cutaneous squamous cell carcinoma (CSCC) treated with either curative intent surgery or radiotherapy is 85-100%. However, the cure rate for locally advanced, recurrent, or metastatic disease to regional nodes following surgery alone are much lower, in the order of 20-70%. Metastatic CSCC is the most common malignancy of the parotid region in Australia.
The 5 year loco-regional control with surgery alone is in the order of 40%-45%. The addition of post-operative radiotherapy improves loco-regional control by 15-20%, and is therefore considered the standard of care in this group of patients.
Recent data have shown that synchronous post-operative chemo-radiotherapy is superior to post-operative radiotherapy alone in "high-risk" mucosal head and neck squamous cell carcinoma (HNSCC). However, to date, there is no evidence from randomised trials that such a benefit exists in CSCC of the head and neck. At present there is little consensus amongst clinicians in Australia as to who should receive post-operative chemo-radiotherapy in CSCC. Although tumour control rates may be improved, the addition of chemotherapy may also significantly increase treatment related toxicity.
Nonetheless, some centres have adopted the use of post-operative chemo-radiotherapy in selected patients with CSCC based on extrapolation from mucosal sites. This has resulted in a wide variability in practice for this disease. Australia is uniquely placed to perform such a trial comparing post-operative chemo-radiotherapy to post-operative radiotherapy alone in high-risk CSCC due to the high rate of skin cancer. Currently there are limited data to guide management of patients with resected CSCC who are at high risk for recurrence. While it is reasonable to hypothesize that concurrent chemotherapy in this setting will confer a similar benefit to that seen in mucosal HNSCC, this can only be established by a randomized trial as proposed. If the addition of chemotherapy is shown to be beneficial and safe, then these results are likely to be translated into standard practice both nationally and internationally quite rapidly. On the other hand, if the treatment is found to be ineffective then patients will be spared the unnecessary toxicity and inconvenience associated with the addition of chemotherapy. A further important aspect of this trial will be the assessment of patient-related outcomes using a validated quality of life questionnaire. It will be important to ascertain whether any improvement in locoregional control due to the addition of chemotherapy, is also associated with improvement in quality of life compared to the control arm.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients have undergone either:
High Risk Nodal Disease
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:
Advanced Primary Disease (TNM 6th Edition 2002) (Appendix 1)
In transit metastases (metastases between the primary site and the adjoining nodal basin)
Exclusion Criteria:
Low risk cervical nodal disease* without advanced primary disease
Contact: Sandro Porceddu | +61 7 3240 2111 | sandro_porceddu@health.qld.gov.au |
United States, Florida | |
University of Florida Shands Cancer Centre | Not yet recruiting |
Gainesville, Florida, United States, 32610 | |
United States, North Carolina | |
Duke University Medical Center | Not yet recruiting |
Durham, North Carolina, United States, 27701 | |
Australia, New South Wales | |
Royal Prince Alfred Hospital | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Principal Investigator: Chris Milross | |
Westmead Hospital | Recruiting |
Wentworthville, New South Wales, Australia, 2145 | |
Principal Investigator: Michael Veness | |
Calvary Mater Newcastle | Recruiting |
Newcastle, New South Wales, Australia, 2298 | |
Principal Investigator: Chris Wratten | |
St George Hospital | Withdrawn |
Kogarah, New South Wales, Australia, 2217 | |
Liverpool Hospital | Recruiting |
Liverpool, New South Wales, Australia, 1871 | |
Principal Investigator: Dion Forstner | |
Royal North Shore Hospital | Recruiting |
St Leonards, New South Wales, Australia, 2065 | |
Principal Investigator: Milan Holecek | |
Riverina Cancer Centre | Recruiting |
Wagga Wagga, New South Wales, Australia, 2650 | |
Principal Investigator: Peter Jeal | |
Illawarra Cancer Care Centre | Not yet recruiting |
Wollongong, New South Wales, Australia, 2500 | |
Australia, Queensland | |
Princess Alexandra Hospital | Recruiting |
Brisbane, Queensland, Australia, 4102 | |
Contact: Sandro Porceddu, FRANZCR +61 7 3240 2111 sandro_porceddu@health.qld.gov.au | |
Principal Investigator: Sandro Porceddu | |
Royal Brisbane Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Principal Investigator: Lizbeth Kenny | |
North Queensland Oncology Service | Recruiting |
Townsville, Queensland, Australia, 4810 | |
Principal Investigator: Michael Collins | |
Mater QRI | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Principal Investigator: Michael Poulsen | |
Premion | Recruiting |
Tugun, Queensland, Australia, 4224 | |
Principal Investigator: david Christie | |
St Andrew's Toowoomba Hospital | Recruiting |
Toowoomba, Queensland, Australia, 4350 | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Principal Investigator: Michael Penniment | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
East Melbourne, Victoria, Australia, 3002 | |
Principal Investigator: Margaret Chua | |
William Buckland Radiotherapy Centre, The Alfred | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Principal Investigator: Sidney Davis | |
St Vincents Melbourne | Recruiting |
Fitzroy, Victoria, Australia | |
Bendigo Radiotherapy Centre | Recruiting |
Bendigo, Victoria, Australia | |
Andrew Love Cancer Care Centre, Geelong Hospital | Recruiting |
Geelong, Victoria, Australia, 3220 | |
Chile | |
Clinica Alemana de Santiago | Not yet recruiting |
Santiago, Chile, 3737 | |
New Zealand | |
Auckland Hospital | Recruiting |
Auckland, New Zealand, 1001 | |
Principal Investigator: Andrew Macann | |
Christchurch Hospital | Recruiting |
Christchurch, New Zealand, 4710 | |
Principal Investigator: Ian Ward | |
Palmerston North Hospital | Recruiting |
Palmerston North, New Zealand | |
Principal Investigator: Nick Nedev | |
Waikato Hospital | Recruiting |
Hamilton, New Zealand, 3200 | |
Principal Investigator: Charles de Groot | |
Wellington Hospital | Active, not recruiting |
Wellington, New Zealand | |
South Africa | |
Johannesburg Hospital | Not yet recruiting |
Johannesburg, South Africa, 2000 |
Study Chair: | Sandro Porceddu | Princess Alexandra Hospital |
Responsible Party: | Trans Tasman Radiation Oncology Group ( Associate Professor Sandro Porceddu ) |
Study ID Numbers: | TROG 05.01 |
Study First Received: | September 13, 2005 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00193895 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Skin cancer radiotherapy chemotherapy surgery |
Skin Diseases Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell of Head and Neck Carboplatin |
Squamous Cell Carcinoma Skin Neoplasms Carcinoma, Squamous Cell Carcinoma |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Head and Neck Neoplasms Carboplatin Skin Neoplasms Pharmacologic Actions |