Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201344
Status:
TERMINATED
Last Update Posted:
2010-03-26
First Post:
2005-09-13
Brief Title:
A Phase III Study of Radiotherapy With or Without Adjuvant CT in Advanced Stage Nasopharyngeal Carcinoma Patients
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
Status:
TERMINATED
Status Verified Date:
2009-06
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:
To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients The endpoints of the study includes overall survival relapse free survival distant metastasis and local-regional control rates
To evaluate the toxicities of the two treatment methods
To evaluate the toxicities of the two treatment methods
Detailed Description:
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancersThere were no significant differences in survival between the two groups but disease free survival was prolonged in the maintenance arm and not in the induction arm Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm Many trials designed several years ago delivered single agent chemotherapy and were not particularly intensive Most clinical trials were dealing with a heterogenous group of head and neck cancer patients We felt that a better choice of adjuvant chemotherapy on cancers should include 1 localized cancers with high metastatic potential following effective local treatment 2 effective chemotherapy available 3 chemotherapy should be intensive and effective enough to avoid the development of drug resistance Of course NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized advanced staged disease
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate decreasing the metastatic rate and local recurrence rate then many NPC patients may benefit
Therefore we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate decreasing the metastatic rate and local recurrence rate then many NPC patients may benefit
Therefore we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients
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