Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
NCT ID: NCT03366883
Last Updated: 2018-01-09
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
PHASE3
420 participants
INTERVENTIONAL
2018-02-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"Paclitaxel, Cisplatin Plus 5-FU (TCF)
preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks
Paclitaxel, Cisplatin Plus 5-FU (TCF)
preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks)
Preoperative radiochemotherapy
preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week
radiochemotherapy
preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week)
Interventions
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Paclitaxel, Cisplatin Plus 5-FU (TCF)
preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks)
radiochemotherapy
preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week)
Eligibility Criteria
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Inclusion Criteria
* All lesions are located in the thoracic esophagus.
* Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
* 20-75 years old.
* ECOG performance status of 0 or 1.
* Measurable lesions not required.
* No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
* No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
* Adequate organ function.
* Written informed consent.
Exclusion Criteria
* Active infection requiring systemic therapy
* Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
* Pregnant or lactating women or women of childbearing potential.
* Patients requiring systemic steroid medication.
* Iodine hypersensitivity.
* Psychiatric disease.
* Hypersensitivity for CremophorEL.
* Poorly controlled diabetes.
* Severe emphysema or pulmonary fibrosis.
* Poorly controlled hypertension.
* Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.
20 Years
75 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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TianjinCIH
Tianjin, Tianjin 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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TianjinCIH20171114
Identifier Type: -
Identifier Source: org_study_id
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