A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma

April 19, 2016 updated by: Jinming Yu, Shandong Cancer Hospital and Institute

A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma

Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary endpoint of this study is overall survival, and the primary hypothesis is the experimental arm will improve median survival time (MST) from 18.2 month to 28.5 month. Assuming bilateral ɑ = 0.05, statistical power of 80%.Each group requires a minimum of 59 cases. Consider the 20% loss factor.The total sample size is 200 cases.It is 100 cases in each group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guangying Zhu
        • Sub-Investigator:
          • Anhui Shi
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Sub-Investigator:
          • Zongmei Zhou
    • Guangdong
      • Shantou, Guangdong, China, 515041
        • Not yet recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhixiong Lin
        • Sub-Investigator:
          • Zhining Yang
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The Guangxi Zhuang Autonomous Region Cancer Hospita
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaodong Zhu
        • Sub-Investigator:
          • Long Chen
    • Guizhou
      • Zunyi, Guizhou, China, 563099
        • Not yet recruiting
        • Affiliated Hospital of Zunyi Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hu Ma
        • Sub-Investigator:
          • Xiaoli Gou
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • Recruiting
        • Fourth Hospital of Hebei Medical University Tumor
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chun Han
        • Sub-Investigator:
          • Jun Wang
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianhua Wang
        • Sub-Investigator:
          • Yongshun Chen
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hong Ji
      • Zhenjiang, Jiangsu, China, 212013
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
          • Dai Chunhua, PhD
          • Phone Number: 13952850012
        • Principal Investigator:
          • Dai Chunhua, PhD
    • Liaoning
      • Shenyang, Liaoning, China, 310022
        • Recruiting
        • The First Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital and Institute
        • Contact:
        • Sub-Investigator:
          • Xue Meng, Ph.D, M.D
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Not yet recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming Ye
        • Sub-Investigator:
          • Xin Xu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Ming Chen
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yujin Xu
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Hospital of Zhejiang Province
        • Contact:
        • Contact:
        • Principal Investigator:
          • Senxiang Yan
        • Sub-Investigator:
          • Haogang Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed written informed consent prior to study entry
  2. age：18-70 years
  3. Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System，2009，Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
  4. The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
  5. Eastern Cooperative Oncology Group（ECOG）Performance status of 0-1
  6. Possible semi-liquid diet
  7. If there is a risk of pregnancy, male and female subjects must be effective contraception during treatment
  8. Normal bone marrow reserve: neutrophil (ANC) count≥1500/mm3,platelet count≥100,000 /mm3, hemoglobin≥5.6mmol/L(9g/dL)
  9. Normal renal function: serum creatinine≤1.5mg/dl and/or calculated creatinine clearance≥ 60ml/min
  10. Normal hepatic function: bilirubin level≤1.5×ULN, alanine aminotransferase aspartate transaminase（ASAT）& ALST≤1.5×ULN
  11. Subjects tumor tissue available for the relevant biomarker detection

Exclusion Criteria:

  1. Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
  2. Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor（VEGF）therapy or EGFR-pathway targeting therapy not indicated in this study protocol
  3. Multiple primary carcinomas of the esophagus
  4. Pregnancy (confirmed by urine β-HCG) or lactation period
  5. Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
  6. There are obvious esophageal ulcers, chest and back more than moderate pain, symptoms of esophageal perforation
  7. Unable to comprehend the study requirements or who are not likely to comply with the study requirements
  8. Patients with distant metastasis
  9. Patients with other malignant disease, except for curable non-melanoma skin cancer, cervical carcinoma in situ or malignant disease cure for≥5 years
  10. Known grade 3 or 4 allergic reaction to any of the study treatment
  11. Peripheral neuropathy > grade 1
  12. Participation in another clinical study within the past 30 days
  13. Significant disease which, in the investigator's opinion, would exclude the patient from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nimotuzumab plus chemoradiotherapy
Nimotuzumab：400mg/w，d1, week 1-7 Paclitaxel：45mg/m2, d1, week 1-7 Cisplatin：20mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
Drug: Nimotuzumab
400mg/w，d1, week 1-7
Other Names:
  • Taixinsheng
Radiation: radiotherapy
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
Drug: chemoradiotherapy Paclitaxel
45 mg/m2, d1, week 1-7
Other Names:
  • Paclitaxel
Drug: chemoradiotherapy Cisplatin
20 mg/m2, d1, week 1-7
Other Names:
  • Cisplatin
Placebo Comparator: placebo plus chemoradiotherapy
placebo：400mg/w，d1, week 1-7 Paclitaxel：45 mg/m2, d1, week 1-7 Cisplatin：20 mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
Radiation: radiotherapy
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
Drug: chemoradiotherapy Paclitaxel
45 mg/m2, d1, week 1-7
Other Names:
  • Paclitaxel
Drug: chemoradiotherapy Cisplatin
20 mg/m2, d1, week 1-7
Other Names:
  • Cisplatin
Other: placebo
400mg/w，d1, week 1-7

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Over Survival
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Cancer Hospital and Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xue Meng, Ph.D, M.D, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NXCEL1311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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