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
  Purpose

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.


Condition Intervention Phase
Chemoradiation
Nasopharyngeal Carcinoma
Drug: PF (cisplatin and 5-fluorouracil) group
Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PF group
the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
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
Experimental: TPF group
TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536223

Contacts
Contact: Xiaozhong Chen, MD 86-571-88122098 cxzfyun@sina.com
Contact: Weifeng Qin, MD 86-571-88122092 qinweifeng@yahoo.com.cn

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    86-571-88122098    cxzfyun@sina.com   
Contact: Weifeng Qin, MD    86-571-88122091    qinweifeng@yahoo.com.cn   
Principal Investigator: Xiaozhong Chen, MD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Xiaozhong Chen, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01536223     History of Changes
Other Study ID Numbers: ZhejiangCH13
Study First Received: February 13, 2012
Last Updated: March 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
Nasopharyngeal Carcinoma (NPC)
cisplatin and 5-fluorouracil (PF)
docetaxel,cisplatin and 5-fluorouracil(TPF)
Neoadjuvant Chemotherapy
intensity modulated radiotherapy(IMRT)

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014