Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
144
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedAugust 20, 2015
August 1, 2015
5.1 years
October 12, 2010
August 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Response rate of Nimotuzumab combined with chemo-irradiation
2 months after radiotherapy
1-yr overall survivals
1 year
2-yr overall survival
2 year
3-yr overall survival
3 years
Secondary Outcomes (5)
Local progression-free survival
3 years
Disease progression-free survival
3 years
Distant metastasis rate
3 years
Number and grade of Participants with Adverse Events
6 months
Quality of life
3 years
Study Arms (2)
Nimotuzumab plus chemo-irradiation
EXPERIMENTALNimotuzumab，chemotherapy(cisplatin )，radiotherapy
Placebo plus chemo-irradiation
PLACEBO COMPARATORPlacebo，chemotherapy(cisplatin)，radiotherapy
Interventions
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)
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)
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).
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 Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 266000, China
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, 350000, China
Cancer Center of Sun Yat-sen
Guangzhou, Guangdong, 510000, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
Wuhan, Hubei, 430000, China
Cancer Hospital of Jiangsu Province
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
Suzhou, Jiangsu, 215006, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
The first bethune hospital of Jilin university
Changchun, Jilin, China
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, 266000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 201100, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 201100, China
Fourth Military Medical University Xijing Hospital
Xian, Shanxi, 710000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2010
First Posted
November 2, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2015
Study Completion
January 1, 2016
Last Updated
August 20, 2015
Record last verified: 2015-08