- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133612
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
April 13, 2015 updated by: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Xiao Lv
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm paclitaxel and 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3 year overall survival
Time Frame: 5 year
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3 year disease-free survival
Time Frame: 5 year
|
5 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jing Huang, M.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
May 5, 2014
First Submitted That Met QC Criteria
May 6, 2014
First Posted (Estimate)
May 8, 2014
Study Record Updates
Last Update Posted (Estimate)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CH-GI-026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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