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

NCT ID: NCT01232374

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nimotuzumab plus chemo-irradiation

Nimotuzumab，chemotherapy(cisplatin )，radiotherapy

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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)

cisplatin

Intervention Type: DRUG

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

Intervention Type: RADIATION

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)

Placebo plus chemo-irradiation

Placebo，chemotherapy(cisplatin)，radiotherapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: RADIATION

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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).

Intervention Type: DRUG

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)

Intervention Type: RADIATION

Other Intervention Names

Nimotuzumab, Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Provincial Tumor Hospital

Fuzhou, Fujian, China

Cancer Center of Sun Yat-sen

Guangzhou, Guangdong, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Huazhong University of Science and Technology, Union Hospital, Tongji Medical College

Wuhan, Hubei, China

Cancer Hospital of Jiangsu Province

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The first bethune hospital of Jilin university

Changchun, Jilin, China

Affiliated Hospital of Qingdao University Medical College

Qingdao, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Fourth Military Medical University Xijing Hospital

Xian, Shanxi, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

BT-ESO-1001

Identifier Type: -

Identifier Source: org_study_id