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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Fudan University
Sponsor:
Collaborators:
The First Affiliated Hospital of Soochow University
NANTONG TUMOR HOSPITAL
Jiangsu Cancer Institute & Hospital
Affiliated Hospital of Jiangsu University
Zhejiang Cancer Hospital
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
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01398449
First received: July 13, 2011
Last updated: July 19, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Esophageal Squamous Cell Carcinoma
Radiation: Elective nodal irradiation (ENI)
Other: Adjuvant chemotherapy only
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • Safety and Tolerability (incidence rate of adverse events) [ Designated as safety issue: Yes ]
    the incidence rate of adverse events, especially radiation-induced lung toxicity

  • Failure pattern [ Designated as safety issue: No ]
    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


Estimated Enrollment: 874
Study Start Date: April 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398449

Contacts
Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 birdhome2000@hotmail.com

Locations
China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xu-Wei Cai, M.D., Ph.D.    8621-64175590 ext 1504    birdhome2000@hotmail.com   
Principal Investigator: Xiao-Long Fu, M.D., Ph.D.         
Sponsors and Collaborators
Fudan University
The First Affiliated Hospital of Soochow University
NANTONG TUMOR HOSPITAL
Jiangsu Cancer Institute & Hospital
Affiliated Hospital of Jiangsu University
Zhejiang Cancer Hospital
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
  More Information

No publications provided

Responsible Party: Xiao-Long Fu / Professor, Fudan University Cancer Center
ClinicalTrials.gov Identifier: NCT01398449     History of Changes
Other Study ID Numbers: 2011ESO_FU_02
Study First Received: July 13, 2011
Last Updated: July 19, 2011
Health Authority: People's Republic of China: State Food and Drug Administration

Keywords provided by Fudan University:
thoracic esophageal squamous cell carcinoma
esophagectomy
elective nodal irradiation
adjuvant chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 24, 2014