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Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Elective nodal irradiation (ENI)
Adjuvant chemotherapy only
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 thoracic esophageal squamous cell carcinoma, esophagectomy, elective nodal irradiation, adjuvant chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 and ≤70
  2. ECOG performance status 0-1
  3. Weight is not less than 90% of it before operation
  4. Registration within 8 weeks after esophagectomy
  5. Histologically proven primary thoracic esophageal squamous cell carcinoma
  6. R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
  7. Stage T1-2N1-3M0 based pathological diagnosis
  8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
  9. Without supraclavicular nodes and abdominal regions nodes existed after surgery
  10. Without neo-adjuvant chemotherapy and radiotherapy
  11. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  12. Platelets ≥ 100X109/L
  13. Hemoglobin ≥ 90g/L(without blood transfusion)
  14. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  15. Creatinine ≤ 1.5 x upper limit of normal
  16. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

  1. Multiple primary esophageal tumors
  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 systemic chemotherapy, 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

B

A

Arm Description

After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)

After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only

Outcomes

Primary Outcome Measures

Overall survival
To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0

Secondary Outcome Measures

Locoregional control rate
Safety and Tolerability (incidence rate of adverse events)
the incidence rate of adverse events, especially radiation-induced lung toxicity
Failure pattern
To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences

Full Information

First Posted
July 13, 2011
Last Updated
July 19, 2011
Sponsor
Fudan University
Collaborators
The First Affiliated Hospital of Soochow University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Jiangsu Cancer Institute & Hospital, Affiliated Hospital of Jiangsu University, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, The First Affiliated Hospital of Anhui Medical University, Anhui Provincial Hospital, Fujian Cancer Hospital, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01398449
Brief Title
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
Official Title
Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
The First Affiliated Hospital of Soochow University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Jiangsu Cancer Institute & Hospital, Affiliated Hospital of Jiangsu University, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, The First Affiliated Hospital of Anhui Medical University, Anhui Provincial Hospital, Fujian Cancer Hospital, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
Detailed Description
Patient Population: Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging. R0 resection; T1-2, N+, M0. Scheme: After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (<3 or >=3). Then patients are randomized to 2 arms: Arm A: Adjuvant chemotherapy (4 cycles). Arm B: Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
thoracic esophageal squamous cell carcinoma, esophagectomy, elective nodal irradiation, adjuvant chemotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
Arm Title
A
Arm Type
Active Comparator
Arm Description
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
Intervention Type
Radiation
Intervention Name(s)
Elective nodal irradiation (ENI)
Intervention Type
Other
Intervention Name(s)
Adjuvant chemotherapy only
Primary Outcome Measure Information:
Title
Overall survival
Description
To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0
Secondary Outcome Measure Information:
Title
Locoregional control rate
Title
Safety and Tolerability (incidence rate of adverse events)
Description
the incidence rate of adverse events, especially radiation-induced lung toxicity
Title
Failure pattern
Description
To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤70 ECOG performance status 0-1 Weight is not less than 90% of it before operation Registration within 8 weeks after esophagectomy Histologically proven primary thoracic esophageal squamous cell carcinoma R0 resection and number of lymph nodes dissected ≥15 after esophagectomy Stage T1-2N1-3M0 based pathological diagnosis Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective) Without supraclavicular nodes and abdominal regions nodes existed after surgery Without neo-adjuvant chemotherapy and radiotherapy 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: Multiple primary esophageal tumors 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 systemic chemotherapy, 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
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

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Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

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