Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193895
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2005-09-13
Brief Title:
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy in High-risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsyear A further 2 years follow up is required
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None