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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01232374
First received: October 12, 2010
Last updated: November 1, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Local Advanced Esophageal Squamous Cell Carcinoma
Drug: Placebo, Radiotherapy and Chemotherapy
Drug: Nimotuzumab, Radiotherapy and Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Biotech Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Response rate of Nimotuzumab combined with chemo-irradiation [ Time Frame: 2 months after radiotherapy ] [ Designated as safety issue: No ]
  • 1-yr overall survivals [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 2-yr overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • 3-yr overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Disease progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Distant metastasis rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number and grade of Participants with Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: August 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimotuzumab plus chemo-irradiation Drug: Nimotuzumab, Radiotherapy and Chemotherapy

Chemotherapy: 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).

Radiotherapy: Started in week 1. 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.

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)

Placebo Comparator: Placebo plus chemo-irradiation Drug: Placebo, Radiotherapy and Chemotherapy

Chemotherapy: 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).

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)


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01232374

Contacts
Contact: Guoliang Jiang, MD, FACR (Hon.) 8621 64439052 jianggl47@hotmail.com

Locations
China, Beijing
Chinese Academy of Medical Sciences Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 266000
Contact: Lvhua Wang       wlhwq@yahoo.com   
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100000
Contact: Guangying Zhu       zgypu@yahoo.com.cn   
China, Fujian
Fujian Provincial Tumor Hospital Not yet recruiting
Fuzhou, Fujian, China, 350000
Contact: Jianji Pan       panjianji@126.com   
China, Guangdong
Cancer Center of Sun Yat-sen Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Mengzhong Liu    13802547520    lmz1955@163.com   
China, Henan
First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
Contact: Qingxia Fan       fqx2243@yahoo.com.cn   
China, Hubei
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Gang Wu       wugangzr@yahoo.com.cn   
China, Jiangsu
Second Affiliated Hospital of Suzhou University Not yet recruiting
Suzhou, Jiangsu, China, 215000
Contact: Ye Tian       dryetian@hotmail.com   
China, Liaoning
Second Affiliated Hospital of China Medical University (Shengjing Hospital) Not yet recruiting
Shenyang, Liaoning, China, 110000
Contact: Rong Wu       wur@sj-hospital.org   
China, Nanjing
Cancer Hospital of Jiangsu Province Not yet recruiting
Nanjing, Nanjing, China, 210000
Contact: Jifeng Feng       fjif@vip.sina.com   
China, Shandong
Affiliated Hospital of Qingdao University Medical College Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: Jun Liang    1396898909      
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200000
Contact: Guo Liang Jiang, MD, FACR (Hon.), Professor    8621-64439052    jianggl47@hotmail.com   
Shanghai Chest Hospital Not yet recruiting
Shanghai, Shanghai, China, 201100
Contact: Changxing Lv         
Shanghai Jiaotong University Renji Hospital Not yet recruiting
Shanghai, Shanghai, China, 201100
Contact: Ming Ye       renjiyeming@gmail.com   
Shanghai First People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 201100
Contact: Guoqi Zhao       zhaogq7i7@yahoo.com.cn   
China, Shanxi
Fourth Military Medical University Xijing Hospital Not yet recruiting
Xian, Shanxi, China, 710000
Contact: Mei Shi       Rtdxjh@fmmu.edu.cn   
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610000
Contact: You Lu    13981935716    radyoulu@hotmail.com   
China, Tianjin
Tianjin Cancer Hospital Not yet recruiting
Tianjin, Tianjin, China, 300000
Contact: Ping Wang    23519953      
China, Zhejiang
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Shenglin Ma         
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Guo-Liang Jiang MD, FACR (Hon.), Professor, Fudan University Shanghai Cancer Center
ClinicalTrials.gov Identifier: NCT01232374     History of Changes
Other Study ID Numbers: BT-ESO-1001
Study First Received: October 12, 2010
Last Updated: November 1, 2010
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
Nimotuzumab
local advanced esophageal squamous cell carcinoma
chemo-irradiation

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014