Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
Conditions
Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
thoracic esophageal squamous cell carcinoma, esophagectomy, elective nodal irradiation, adjuvant chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Elective nodal irradiation (ENI) Type: Radiation
Name: Adjuvant chemotherapy only Type: Other
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Fudan University Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Xu-Wei Cai, M.D., Ph.D. - 8621-64175590 - birdhome2000@hotmail.com
Start Date
April 2011
Completion Date
December 2017
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page