Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
NCT ID: NCT01398449
Last Updated: 2011-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
874 participants
INTERVENTIONAL
2011-04-30
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
Elective nodal irradiation (ENI)
A
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
Adjuvant chemotherapy only
Interventions
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Elective nodal irradiation (ENI)
Adjuvant chemotherapy only
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Affiliated Hospital of Jiangsu University
OTHER
Zhejiang Cancer Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Zhejiang University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Anhui Provincial Hospital
OTHER_GOV
Fujian Cancer Hospital
OTHER_GOV
Shanghai Chest Hospital
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
RenJi Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Fudan University Cancer Center
Locations
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Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2011ESO_FU_02
Identifier Type: -
Identifier Source: org_study_id
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