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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Zhejiang Cancer Hospital
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang University
Zhejiang Provincial People’s Hospital
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Wenzhou Medical University
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01536223
First received: February 13, 2012
Last updated: March 3, 2013
Last verified: April 2012

February 13, 2012
March 3, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
3-year progress free survival(PFS) [ Time Frame: 3 years after the inception assignment ] [ Designated as safety issue: No ]
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.
3-year progress free survival(PFS) [ Time Frame: 3 years after the inception assignment ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01536223 on ClinicalTrials.gov Archive Site
  • overall survival(OS) [ Time Frame: 2 years ,3 years and 5 years after the inception of the assignment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • overall survival(OS) [ Time Frame: 2 years ,3 years and 5 years after the inception of the assignment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chemoradiation
  • Nasopharyngeal Carcinoma
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
February 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Xiaozhong Chen, MD 86-571-88122098 cxzfyun@sina.com
Contact: Weifeng Qin, MD 86-571-88122092 qinweifeng@yahoo.com.cn
China
 
NCT01536223
ZhejiangCH13
Yes
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Zhejiang University
  • Zhejiang Provincial People’s Hospital
  • Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
  • Wenzhou Medical University
Principal Investigator: Xiaozhong Chen, MD Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
April 2012

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