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
1 other identifier
interventional
386
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 30, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 1, 2015
August 1, 2015
5.7 years
May 30, 2015
August 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3 year relapse free survival
5 years
Secondary Outcomes (1)
3 year overall survival
5 years
Other Outcomes (1)
5 year overall survival
8 years
Study Arms (2)
Arm A
EXPERIMENTALchemotherapy and radiotherapy
Arm B
ACTIVE COMPARATORradiotherapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior chemotherapy or concurrent radiation therapy before esophagectomy
- R1 or R2 resection
- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD.,PhD
Study Record Dates
First Submitted
May 30, 2015
First Posted
June 3, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2023
Last Updated
September 1, 2015
Record last verified: 2015-08