Back to resultsAdjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
paclitaxel; cisplatin
radiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel
Eligibility Criteria
Inclusion Criteria:
- ability to give informed consent
- 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:
- prior chemotherapy or concurrent radiation therapy before esophagectomy
- R1 or R2 resection
- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
chemotherapy and radiotherapy
radiotherapy
Outcomes
Primary Outcome Measures
3 year relapse free survival
Secondary Outcome Measures
3 year overall survival
Full Information
NCT ID
NCT02461043
First Posted
May 30, 2015
Last Updated
August 29, 2015
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02461043
Brief Title
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
Official Title
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
chemotherapy and radiotherapy
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
radiotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel; cisplatin
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiation
Primary Outcome Measure Information:
Title
3 year relapse free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
3 year overall survival
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
5 year overall survival
Time Frame
8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ability to give informed consent
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:
prior chemotherapy or concurrent radiation therapy before esophagectomy
R1 or R2 resection
clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang
Phone
8610-87788102
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wang, M.D
First Name & Middle Initial & Last Name & Degree
Jie He, M.D.
12. IPD Sharing Statement
Learn more about this trial
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
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