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Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

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: NCT01232374
Recruitment Status : Unknown
Verified August 2015 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2010
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE November 2, 2010
Last Update Posted Date August 20, 2015
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
  • Response rate of Nimotuzumab combined with chemo-irradiation [ Time Frame: 2 months after radiotherapy ]
  • 1-yr overall survivals [ Time Frame: 1 year ]
  • 2-yr overall survival [ Time Frame: 2 year ]
  • 3-yr overall survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
  • Local progression-free survival [ Time Frame: 3 years ]
  • Disease progression-free survival [ Time Frame: 3 years ]
  • Distant metastasis rate [ Time Frame: 3 years ]
  • Number and grade of Participants with Adverse Events [ Time Frame: 6 months ]
  • Quality of life [ 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 Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
Official Title  ICMJE A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma
Brief Summary Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
Detailed Description The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Nimotuzumab
    200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
  • Drug: Placebo
    4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
    Other Name: Nimotuzumab, Placebo
  • Drug: cisplatin
    cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
  • Radiation: Radiotherapy

    A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

    Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)

Study Arms  ICMJE
  • Experimental: Nimotuzumab plus chemo-irradiation
    Nimotuzumab,chemotherapy(cisplatin ),radiotherapy
    Interventions:
    • Drug: Nimotuzumab
    • Drug: cisplatin
    • Radiation: Radiotherapy
  • Placebo Comparator: Placebo plus chemo-irradiation
    Placebo,chemotherapy(cisplatin),radiotherapy
    Interventions:
    • Drug: Placebo
    • Drug: cisplatin
    • Radiation: 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2010)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75
  • Both genders
  • Esophageal squamous cell carcinoma confirmed by pathology
  • Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Target lesions measurable
  • Hemoglobin(Hb)≥9 g/dL
  • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  • platelet count (Pt) ≥100x 109/L
  • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

  • Complete esophageal obstruction
  • Deep esophageal ulcer
  • Esophageal perforation
  • Haematemesis
  • After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  • Esophageal stent or tracheal stent placed
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction
  • Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • History of serious allergic or allergy
  • Patients who are not suitable to participate in the trial according to researchers.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 NCT01232374
Other Study ID Numbers  ICMJE BT-ESO-1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotech Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Biotech Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biotech Pharmaceutical Co., Ltd.
Verification Date August 2015

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