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Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

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ClinicalTrials.gov Identifier: NCT02012062
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
Fujian Province Tumor Hospital
The First Affiliated Hospital of Xiamen University
Information provided by (Responsible Party):
Lin Kong, Fudan University

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 16, 2013
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) [ Time Frame: From Day 1 to Day 90 of radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • PFS [ Time Frame: 3 years ]
  • OS [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
Official Title  ICMJE Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Brief Summary The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
Detailed Description

Scheme:

Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

- Arm nimotuzumab:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT

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 Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: TPF neoadjuvant chemotherapy
  • Drug: Concurrent chemotherapy with cisplatin during radiotherapy
  • Drug: Concurrent nimotuzumab during radiotherapy
  • Radiation: Radical radiotherapy
Study Arms  ICMJE
  • Active Comparator: Arm Cisplatin
    Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
    Interventions:
    • Drug: TPF neoadjuvant chemotherapy
    • Drug: Concurrent chemotherapy with cisplatin during radiotherapy
    • Radiation: Radical radiotherapy
  • Experimental: Arm Nimotuzumab
    Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
    Interventions:
    • Drug: TPF neoadjuvant chemotherapy
    • Drug: Concurrent nimotuzumab during radiotherapy
    • Radiation: Radical radiotherapy
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
320
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
  • Stage III and IVA/B NPC patients
  • KPS >70
  • Age between 18-70
  • AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min

Exclusion Criteria:

  • Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
  • Prior radiation treatment to the head and neck or any prior chemotherapy
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 NCT02012062
Other Study ID Numbers  ICMJE NPC-IMRT-N
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lin Kong, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE
  • Fujian Province Tumor Hospital
  • The First Affiliated Hospital of Xiamen University
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date April 2019

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