Cetuximab/Paclitaxel/Cisplatin Concurrent Chemoradiotherapy Followed by Esophagectomy for Loco-regional Esophageal Cancer
NCT ID: NCT01034189
Last Updated: 2009-12-17
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
62 participants
INTERVENTIONAL
2008-10-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
Cetuximab
Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3\~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).
Paclitaxel
T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.
Cisplatin
P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.
Radiotherapy
Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.
Interventions
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Cetuximab
Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3\~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).
Paclitaxel
T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.
Cisplatin
P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.
Radiotherapy
Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Loco-regional diseases, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (6th edition) in 2002, fulfilling one of the following criteria:
A. T3, N0, M0; B. T1-3, N1, M0; C. T1-3 or N0-1, M1a will be eligible provided the lesions could be covered by appropriate radiation fields.
3. Age ≥ 18 years old.
4. Performance status ECOG 0\~2.
5. Adequate bone marrow reserves, defined as:
A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
6. Adequate liver function reserves, defined as:
A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 1.5 x upper limit of normal (ULN).
7. Adequate renal function: Creatinine ≤1.5 mg/dl
8. Written informed consent.
3. Adenocarcinoma of gastroesophageal (GE) junction.
4. Prior thoracic irradiation.
5. Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
6. Prior malignancy, except for the following:
A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. Note: previously treated aerodigestive squamous cell carcinoma is not allowed.
7. Significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
8. Estimated life expectancy less than 3 months.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Principal Investigators
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Yung-Chie Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chih-Hung Hsu, M.D., Ph.D.
Role: primary
References
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Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
Other Identifiers
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200803088M
Identifier Type: -
Identifier Source: org_study_id