Overview

This trial is active, not recruiting.

Condition squamous cell carcinoma
Treatments nimotuzumab, placebo, cisplatin, radiotherapy
Phase phase 2
Target EGFR
Sponsor Biotech Pharmaceutical Co., Ltd.
Start date September 2010
End date October 2015
Trial size 144 participants
Trial identifier NCT01232374, BT-ESO-1001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Nimotuzumab,chemotherapy(cisplatin ),radiotherapy
nimotuzumab 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)
cisplatin 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).
radiotherapy 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)
(Placebo Comparator)
Placebo,chemotherapy(cisplatin),radiotherapy
placebo Nimotuzumab, 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)
cisplatin 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).
radiotherapy 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)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Biotech Pharmaceutical Co., Ltd..