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

July 19, 2011 updated by: Fudan University

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

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

874

Phase

  • 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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiao-Long Fu, M.D., Ph.D.

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

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. 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
Radiation: Elective nodal irradiation (ENI)
Active Comparator: A
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
Other: Adjuvant chemotherapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

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

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

April 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011ESO_FU_02

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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