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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma Resectable

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab combined with paclitaxel and cisplatin

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma Resectable focused on measuring Esophageal Squamous Cell Carcinoma, neoadjuvant therapy, Nimotuzumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or cytologic diagnosis of Esophageal squamous cell carcinoma
ECOG performance status 0-2
Age:18-70 years
Joined the study voluntarily and signed informed consent form
Patients must not have received any prior anticancer therapy
Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009）
Target lesions can be measured according to RECIST criteria
No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
Use of an effective contraceptive for adults to prevent pregnancy
Life expectancy of more than 3 months

Exclusion Criteria:

Not suitable to surgery
cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
early Esophageal Carcinoma(Stage I)
complete esophageal obstruction，Esophageal perforation or hematemesis
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab plus chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Pathology complete remission rate

Pathology complete remission rate is the primary outcome measure.

Secondary Outcome Measures

R0 resection rate

objective response rate

Objective response rate of neoadjuvant chemotherapy will be assessed.

overall survival

tolerability and safety

number of adverse events such as leucopenia ,rash,diarrhea and so on

Quality of life

Quality of life of patients will be evaluated during and after therapy.

Full Information

NCT ID

NCT01688700

First Posted

September 16, 2012

Last Updated

September 19, 2012

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01688700

Brief Title

Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Official Title

A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity

Detailed Description

A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases. A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma 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 neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma Resectable

Keywords

Esophageal Squamous Cell Carcinoma, neoadjuvant therapy, Nimotuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab plus chemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab combined with paclitaxel and cisplatin

Intervention Description

Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22 paclitaxel: 90mg/m2, IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.

Primary Outcome Measure Information:

Title

Pathology complete remission rate

Description

Pathology complete remission rate is the primary outcome measure.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

R0 resection rate

Time Frame

1 year

Title

objective response rate

Description

Objective response rate of neoadjuvant chemotherapy will be assessed.

Time Frame

1 year

Title

overall survival

Time Frame

5 years

Title

tolerability and safety

Description

number of adverse events such as leucopenia ,rash,diarrhea and so on

Time Frame

2 years

Title

Quality of life

Description

Quality of life of patients will be evaluated during and after therapy.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytologic diagnosis of Esophageal squamous cell carcinoma ECOG performance status 0-2 Age:18-70 years Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009） Target lesions can be measured according to RECIST criteria No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN Use of an effective contraceptive for adults to prevent pregnancy Life expectancy of more than 3 months Exclusion Criteria: Not suitable to surgery cervical Esophageal Carcinoma(distance of incisor tooth<19cm) early Esophageal Carcinoma(Stage I) complete esophageal obstruction，Esophageal perforation or hematemesis other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yun Fan, Doctor

Phone

0086-571-88122192

fanyun@csco.org.cn

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yun Fan, doctor

Phone

0086-571-88122192

fanyun@csco.org.cn

First Name & Middle Initial & Last Name & Degree

Weimin Mao, doctor

12. IPD Sharing Statement

Learn more about this trial

Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

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