Status:
UNKNOWN
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
Lead Sponsor:
Fudan University
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 esoph...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
874 Patients enrolled
Trial Details
Trial ID
NCT01398449
Start Date
April 1 2011
End Date
December 1 2017
Last Update
July 20 2011
Active Locations (1)
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1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032