Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma
NCT ID: NCT02461043
Last Updated: 2015-09-01
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
386 participants
INTERVENTIONAL
2015-04-30
2023-12-31
Brief Summary
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* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.
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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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Arm A
chemotherapy and radiotherapy
paclitaxel; cisplatin
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
radiation
radiation
Arm B
radiotherapy
radiation
radiation
Interventions
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paclitaxel; cisplatin
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
radiation
radiation
Eligibility Criteria
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Inclusion Criteria
* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
* node-positive and pathologic stage M0
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients were enrolled 4 to 10 weeks after surgery
* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits
Exclusion Criteria
* R1 or R2 resection
* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jie He
MD.,PhD
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Jing Huang
Role: CONTACT
Facility Contacts
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Xi Wang, M.D
Role: primary
Other Identifiers
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CH-GI-046
Identifier Type: -
Identifier Source: org_study_id
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