A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer
NCT ID: NCT01391572
Last Updated: 2011-07-22
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
PHASE2
300 participants
INTERVENTIONAL
2011-04-30
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.
T3-4, any N, M0.
Scheme:
After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node metastasis (\<3 or \>=3) and (2)tumor resection status (R1 resection or R2 resection).
Note: Pathological R0 resection status is required for this study. So here R1 and R2 resection are not actually pathological status of resection, only clinical judgement by physician based on the chest-CT before esophagectomy.
Then patients are randomized to 2 arms:
Arm A:
Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy (4 cycles).
Arm B:
Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
enlarge irradiation volume
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
cisplatin
fluorouracil
B
After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
Small volume radiation
In Arm B, postsurgical radiation target volume includes tumor bed only
cisplatin
fluorouracil
Interventions
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enlarge irradiation volume
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
Small volume radiation
In Arm B, postsurgical radiation target volume includes tumor bed only
cisplatin
fluorouracil
Eligibility Criteria
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Inclusion Criteria
2. 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. Pathological stage of T3-4N0-3M0
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
Principal Investigators
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Xiao-Long Fu, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
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_01
Identifier Type: -
Identifier Source: org_study_id
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