Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201396
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2005-09-13
Brief Title:
A Multicenter Trial Comparing Induction CT Followed by CCRT vs CCRT Alone in Stage IV Nasopharyngeal Carcinoma
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma NPC
Status:
COMPLETED
Status Verified Date:
2006-05
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:
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy CCRT on the disease control and survival in treatment of patients with advanced NPC
Detailed Description:
Rationale of induction chemotherapy
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC but it is still flawed by high incidence of distant metastasis
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC
Objectives
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy CCRT on the disease control and survival in treatment of patients with advanced NPC
Study design
This is a randomized multi-center Phase III study Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy
Type and number of patients
Patients with stage IVA T4 andor IVB N3 but without distant metastasis will be enrolled A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 58 to 87 years with an a005 and power of 08 using a two-sided logrank test with one interim analysis
Treatment schedule
Induction chemotherapy and CCRT
Arm A Weekly cisplatin concurrently with radiotherapy Arm B Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy
Study endpoints
The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after induction chemotherapyCCRT or death from any cause failed or the date of withdrawal last contact date censored or the scheduled data analysis date censored revised 8272004
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC but it is still flawed by high incidence of distant metastasis
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC
Objectives
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy CCRT on the disease control and survival in treatment of patients with advanced NPC
Study design
This is a randomized multi-center Phase III study Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy
Type and number of patients
Patients with stage IVA T4 andor IVB N3 but without distant metastasis will be enrolled A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 58 to 87 years with an a005 and power of 08 using a two-sided logrank test with one interim analysis
Treatment schedule
Induction chemotherapy and CCRT
Arm A Weekly cisplatin concurrently with radiotherapy Arm B Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy
Study endpoints
The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after induction chemotherapyCCRT or death from any cause failed or the date of withdrawal last contact date censored or the scheduled data analysis date censored revised 8272004
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