Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01614938
Recruitment Status : Unknown
Verified June 2012 by Guo-Pei Zhu, Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2012
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Guo-Pei Zhu, Fudan University

Tracking Information
First Submitted Date  ICMJE June 5, 2012
First Posted Date  ICMJE June 8, 2012
Last Update Posted Date June 8, 2012
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
Progression-free survival [ Time Frame: up to 3 years ]
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • Overall survival [ Time Frame: up to 3 years ]
    The time from date of randomization until date of death due to any cause, assessed up to 3 years.
  • Locoregional recurrence-free survival [ Time Frame: up to 3 years ]
    The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.
  • Distant metastasis-free survival [ Time Frame: up to 3 years ]
    The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.
  • Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0 [ Time Frame: 1, 2, 3 weeks post-dose ]
  • Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
  • Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0 [ Time Frame: Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy ]
  • Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    QoL score will be documented on each weekend during the course of radiotherapy
  • Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy [ Time Frame: At 3 months after completion of radiotherapy ]
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 Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer
Official Title  ICMJE Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Brief Summary The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.
Detailed Description Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al. demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did not increase the treatment induced toxicities when compared with RT alone. Therefore, we initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for locally advanced NPC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Cetuximab
    400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
    Other Name: Erbitux
  • Drug: Cisplatin
    2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
    Other Name: Platinol
  • Drug: Docetaxel
    2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
    Other Name: Taxotere
  • Radiation: Intensity-modulated radiotherapy
    a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor
    Other Name: IMRT
  • Drug: Cisplatin
    2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1
    Other Name: Platinol
Study Arms  ICMJE
  • Active Comparator: cisplatin-radiotherapy (CRT)
    The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
    Interventions:
    • Drug: Docetaxel
    • Radiation: Intensity-modulated radiotherapy
    • Drug: Cisplatin
  • Experimental: cetuximab-radiotherapy (ERT)
    The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
    Interventions:
    • Drug: Cetuximab
    • Drug: Cisplatin
    • Drug: Docetaxel
    • Radiation: Intensity-modulated radiotherapy
Publications * Xu T, Liu Y, Dou S, Li F, Guan X, Zhu G. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. Oral Oncol. 2015 Sep;51(9):875-9. doi: 10.1016/j.oraloncology.2015.06.008. Epub 2015 Jul 7.

*   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
Actual Enrollment  ICMJE
 (submitted: June 6, 2012)
46
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
  3. ECOG performance status of 0-1
  4. Life expectancy of more than 6 months
  5. Signed written informed consent
  6. Adequate organ function including the following:

    • Absolute neutrophil count (ANC) >= 1.5 * 109/l
    • Platelets count >= 100 * 109/l
    • Hemoglobin >= 10 g/dl
    • AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
    • Total bilirubin <= 1.5 times institutional ULN
    • Creatinine clearance >= 50 ml/min
    • Serum creatine <= 1 times ULN

Exclusion Criteria:

  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
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 NCT01614938
Other Study ID Numbers  ICMJE HN201002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guo-Pei Zhu, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guopei Zhu, M.D. Fudan University
PRS Account Fudan University
Verification Date June 2012

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