Back to resultsTPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Drug: Taxol,cisplatin and capecitabine
Drug: Cisplatin and 5-Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, induction chemotherapy
Eligibility Criteria
Inclusion Criteria:
- WHO II or III pathological type
- stage Ⅳa or Ⅳb (UICC 7th edition)
- no anticancer treatment before
- no malignant history
- both gender, 18-60 years old
- enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
- enough kidney function: Clcr≥80 mL/min
- enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
- no sever heart, lung disfunction
- PS≤2
Exclusion Criteria:
- previous anticancer treatment
- distant metastasis
- pregnant or breasting female
- can not access to followup
- enrolled in other therapeutic clinical trial
- sever infection and internal disease
- sever disfunction of heart, lung, kidney, liver, etc
- TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
- with factors that will affect the administration, distribution,metabolism or evacuation.
- using immunosuppressive agents after organ transplantation
- other malignant history
Sites / Locations
- SunYat-senU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug: Taxol,cisplatin and capecitabine
Drug: Cisplatin and 5-Fluorouracil
Arm Description
Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Outcomes
Primary Outcome Measures
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
Secondary Outcome Measures
Overall survival calculated from randomisation to death from any cause
Progression free survival calculated from randomisation to disease progression or death from any cause
Local-regionally relapse free survival calculated from randomisation to locoregional failure
Distant metastasis free survival calculated from randomisation to distant failure
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT02940925
First Posted
September 21, 2016
Last Updated
April 11, 2023
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02940925
Brief Title
TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma
Official Title
TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.
Detailed Description
This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS）.The secondary endpoints are overall survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS), distant metastasis free survival（DMFS)and toxicities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, induction chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: Taxol,cisplatin and capecitabine
Arm Type
Experimental
Arm Description
Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).
Arm Title
Drug: Cisplatin and 5-Fluorouracil
Arm Type
Active Comparator
Arm Description
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Intervention Type
Other
Intervention Name(s)
Drug: Taxol,cisplatin and capecitabine
Intervention Description
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Intervention Type
Other
Intervention Name(s)
Drug: Cisplatin and 5-Fluorouracil
Intervention Description
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Primary Outcome Measure Information:
Title
Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival calculated from randomisation to death from any cause
Time Frame
up to 5 years
Title
Progression free survival calculated from randomisation to disease progression or death from any cause
Time Frame
up to 5 years
Title
Local-regionally relapse free survival calculated from randomisation to locoregional failure
Time Frame
up to 5 years
Title
Distant metastasis free survival calculated from randomisation to distant failure
Time Frame
up to 5 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
WHO II or III pathological type
stage Ⅳa or Ⅳb (UICC 7th edition)
no anticancer treatment before
no malignant history
both gender, 18-60 years old
enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
enough kidney function: Clcr≥80 mL/min
enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
no sever heart, lung disfunction
PS≤2
Exclusion Criteria:
previous anticancer treatment
distant metastasis
pregnant or breasting female
can not access to followup
enrolled in other therapeutic clinical trial
sever infection and internal disease
sever disfunction of heart, lung, kidney, liver, etc
TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
with factors that will affect the administration, distribution,metabolism or evacuation.
using immunosuppressive agents after organ transplantation
other malignant history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqun Xiang
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Taize Yuan
Organizational Affiliation
Cancer Center of Guangzhou medical school
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yunxiang He
Organizational Affiliation
Xiangya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SunYat-senU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The diagnosis, treatment regimen, toxicity and followup data will be shared once every year through email, phone or meeting.
Citations:
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TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma
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