Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy
NCT ID: NCT01402180
Last Updated: 2011-07-26
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/PHASE3
128 participants
INTERVENTIONAL
2010-12-31
2015-12-31
Brief Summary
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Detailed Description
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Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy.
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio.
Arm A:
Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation.
Arm B:
Chemoradiation only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
Nimotuzumab
Radiation therapy
chemotherapy
B
Patients randomized in Arm B will receive chemoradiation only
radiation therapy
chemotherapy
Interventions
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Nimotuzumab
Radiation therapy
radiation therapy
chemotherapy
chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-2
3. Histologically proven primary thoracic esophageal squamous cell carcinoma before
4. Diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
5. Period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
6. Without prior radiotherapy
7. Weight loss no more than 10% in the past 6 months
8. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
9. Platelets ≥ 100X109/L
10. Hemoglobin ≥ 90g/L(without blood transfusion)
11. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
12. Creatinine ≤ 1.5 x upper limit of normal
13. 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 radiation therapy or prior target drug therapy
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
RenJi Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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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2010ESO_FU
Identifier Type: -
Identifier Source: org_study_id
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