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

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ClinicalTrials.gov Identifier: NCT01536223
Recruitment Status : Unknown
Verified April 2012 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : February 20, 2012
Last Update Posted : March 5, 2013
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang University
Zhejiang Provincial People's Hospital
Sir Run Run Shaw Hospital
Wenzhou Medical University
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE February 13, 2012
First Posted Date  ICMJE February 20, 2012
Last Update Posted Date March 5, 2013
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2013)
3-year progress free survival(PFS) [ Time Frame: 3 years after the inception assignment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2012)
3-year progress free survival(PFS) [ Time Frame: 3 years after the inception assignment ]
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates,and find out is there significant differcence betweet these two groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2013)
  • overall survival(OS) [ Time Frame: 2 years ,3 years and 5 years after the inception of the assignment ]
    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 [ 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 ]
    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) [ Time Frame: 1 year ,2 years,3 years and 5 years after the inception of the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2012)
  • overall survival(OS) [ Time Frame: 2 years ,3 years and 5 years after the inception of the assignment ]
    the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
  • Adverse events [ 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 ]
    observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the neoadjuvant chemotherapy ,chemoratiation and follow-up.
  • local control rate (LCR) [ Time Frame: 1 year ,2 years,3 years and 5 years after the inception of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chemoradiation
  • Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: PF (cisplatin and 5-fluorouracil) group
    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.
    Other Name: Active Comparator group
  • Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group

    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.

    Other Name: Experiment group
Study Arms  ICMJE
  • Active Comparator: PF group
    the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
    Intervention: Drug: PF (cisplatin and 5-fluorouracil) group
  • Experimental: TPF group
    TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
    Intervention: Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2012)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2015
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01536223
Other Study ID Numbers  ICMJE ZhejiangCH13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Zhejiang University
  • Zhejiang Provincial People's Hospital
  • Sir Run Run Shaw Hospital
  • Wenzhou Medical University
Investigators  ICMJE
Principal Investigator: Xiaozhong Chen, MD Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP