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Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy (Nimotuzumab)

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Radiation therapy
radiation therapy
chemotherapy
chemotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, lymph nodes recurrence, chemoradiation, Nimotuzumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 and ≤75
  2. ECOG performance status 0-2
  3. Histologically proven primary thoracic esophageal squamous cell carcinoma before
  4. Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
  5. Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
  6. Without prior radiotherapy
  7. Weight loss no more than 10% in the past 6 months
  8. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  9. Platelets ≥ 100X109/L
  10. Hemoglobin ≥ 90g/L(without blood transfusion)
  11. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  12. Creatinine ≤ 1.5 x upper limit of normal
  13. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

  1. With recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  3. Severe, active comorbidity, defined as follows:

    3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

  4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  5. Prior radiation therapy or prior target drug therapy

Sites / Locations

  • Fudan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation

Patients randomized in Arm B will receive chemoradiation only

Outcomes

Primary Outcome Measures

Local control
To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.

Secondary Outcome Measures

Overall survival
To evaluate if the addition of nimotuzumab to chemoradiation improves overall survival compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Adverse Events

Full Information

First Posted
July 25, 2011
Last Updated
July 25, 2011
Sponsor
Fudan University
Collaborators
Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01402180
Brief Title
Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy
Acronym
Nimotuzumab
Official Title
A Randomized Phase II Trial Evaluating The Addition Of Nimotuzumab To Chemoradiation For Patients With Esophageal Squamous Cell Carcinoma After Radical Esophagectomy Who Suffer With Lymph Nodes Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to chemoradiation for patients with esophageal squamous cell carcinoma after radical esophagectomy who suffer with locoregional lymph nodes recurrence.
Detailed Description
Patient population: Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy. Scheme: Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio. Arm A: Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation. Arm B: Chemoradiation only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Esophageal squamous cell carcinoma, lymph nodes recurrence, chemoradiation, Nimotuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients randomized in Arm B will receive chemoradiation only
Intervention Type
Biological
Intervention Name(s)
Nimotuzumab
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Primary Outcome Measure Information:
Title
Local control
Description
To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Secondary Outcome Measure Information:
Title
Overall survival
Description
To evaluate if the addition of nimotuzumab to chemoradiation improves overall survival compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Title
Adverse Events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤75 ECOG performance status 0-2 Histologically proven primary thoracic esophageal squamous cell carcinoma before Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months Without prior radiotherapy Weight loss no more than 10% in the past 6 months WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L Platelets ≥ 100X109/L Hemoglobin ≥ 90g/L(without blood transfusion) AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal Creatinine ≤ 1.5 x upper limit of normal Sign study-specific informed consent prior to study entry Exclusion Criteria: With recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Severe, active comorbidity, defined as follows: 3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. Prior radiation therapy or prior target drug therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu-Wei Cai, M.D., Ph.D.
Phone
8621-64175590
Ext
1504
Email
birdhome2000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Long Fu, M.D, Ph.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu-Wei Cai, M.D., Ph.D.
Phone
8621-64175590
Ext
1504
Email
birdhome2000@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiao-Long Fu, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy

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