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Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma (ESNCCT)

Primary Purpose

Chemoradiation, Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PF (cisplatin and 5-fluorouracil) group
TPF (docetaxel plus cisplatin and 5-fluorouracil) group
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemoradiation focused on measuring Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma.
  2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
  3. No evidence of distant metastasis(M0)
  4. Performance status:KPS>70
  5. With normal liver function test(ALT, AST<1.5ULN)
  6. Renal:creatinine clearance >60ml/min
  7. Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L.
  8. With controled blood glucose for diabetes patients
  9. Written informed consent

Exclusion Criteria:

  1. WHO type I squamous cell carcinoma or adenocarcinoma
  2. Age>70 or <18
  3. With a history of renal disease
  4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
  5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
  6. Patient is pregnant or lactating .
  7. Peripheral neuropathy
  8. Emotional disturbance

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PF group

TPF group

Arm Description

the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy

TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy

Outcomes

Primary Outcome Measures

3-year progress free survival(PFS)
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.

Secondary Outcome Measures

overall survival(OS)
the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
Adverse events
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.
local control rate (LCR)

Full Information

First Posted
February 13, 2012
Last Updated
March 3, 2013
Sponsor
Zhejiang Cancer Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang University, Zhejiang Provincial People's Hospital, Sir Run Run Shaw Hospital, Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01536223
Brief Title
Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
Acronym
ESNCCT
Official Title
Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang University, Zhejiang Provincial People's Hospital, Sir Run Run Shaw Hospital, Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Detailed Description
For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle. After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemoradiation, Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PF group
Arm Type
Active Comparator
Arm Description
the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
Arm Title
TPF group
Arm Type
Experimental
Arm Description
TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
PF (cisplatin and 5-fluorouracil) group
Other Intervention Name(s)
Active Comparator group
Intervention Description
the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
Intervention Type
Drug
Intervention Name(s)
TPF (docetaxel plus cisplatin and 5-fluorouracil) group
Other Intervention Name(s)
Experiment group
Intervention Description
3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
Primary Outcome Measure Information:
Title
3-year progress free survival(PFS)
Description
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
Time Frame
3 years after the inception assignment
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
Time Frame
2 years ,3 years and 5 years after the inception of the assignment
Title
Adverse events
Description
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.
Time Frame
participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
Title
local control rate (LCR)
Time Frame
1 year ,2 years,3 years and 5 years after the inception of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system) No evidence of distant metastasis(M0) Performance status:KPS>70 With normal liver function test(ALT, AST<1.5ULN) Renal:creatinine clearance >60ml/min Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L. With controled blood glucose for diabetes patients Written informed consent Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age>70 or <18 With a history of renal disease Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0 Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating . Peripheral neuropathy Emotional disturbance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Chen, MD
Phone
86-571-88122098
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Qin, MD
Phone
86-571-88122092
Email
qinweifeng@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
86-571-88122098
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name & Degree
Weifeng Qin, MD
Phone
86-571-88122091
Email
qinweifeng@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30797141
Citation
Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.
Results Reference
derived

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Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

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