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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01232374
First received: October 12, 2010
Last updated: August 19, 2015
Last verified: August 2015
  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
Squamous Cell Carcinoma
Drug: Nimotuzumab
Drug: Placebo
Drug: cisplatin
Radiation: Radiotherapy
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: September 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimotuzumab plus chemo-irradiation
Nimotuzumab,chemotherapy(cisplatin ),radiotherapy
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)
Other Name: nimotuzumab
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).
Other Name: cisplatin
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)

Other Name: Radiotherapy
Placebo Comparator: Placebo plus chemo-irradiation
Placebo,chemotherapy(cisplatin),radiotherapy
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).
Other Name: cisplatin
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)

Other Name: Radiotherapy

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.

  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

Locations
China, Beijing
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing, China, 266000
China, Fujian
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China, 350000
China, Guangdong
Cancer Center of Sun Yat-sen
Guangzhou, Guangdong, China, 510000
China, Henan
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hubei
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
Wuhan, Hubei, China, 430000
China, Jiangsu
Cancer Hospital of Jiangsu Province
Nanjing, Jiangsu, China, 210000
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
Suzhou, Jiangsu, China, 215006
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
China, Jilin
The first bethune hospital of Jilin university
Changchun, Jilin, China
China, Shandong
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, China, 266000
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200000
Shanghai Chest Hospital
Shanghai, Shanghai, China, 201100
Shanghai First People's Hospital
Shanghai, Shanghai, China, 201100
China, Shanxi
Fourth Military Medical University Xijing Hospital
Xian, Shanxi, China, 710000
China, Tianjin
Tianjin Cancer Hospital
Tianjin, Tianjin, China, 300000
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01232374     History of Changes
Other Study ID Numbers: BT-ESO-1001
Study First Received: October 12, 2010
Last Updated: August 19, 2015
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
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015