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Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
paclitaxel; cisplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Xiao Lv

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm paclitaxel and cisplatin

Arm Description

Outcomes

Primary Outcome Measures

3 year overall survival

Secondary Outcome Measures

3 year disease-free survival

Full Information

First Posted
May 5, 2014
Last Updated
April 13, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02133612
Brief Title
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
Official Title
Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

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, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm paclitaxel and cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
paclitaxel; cisplatin
Other Intervention Name(s)
Paclitaxel Injection, Beijing Union Pharmaceutical Factory
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.
Primary Outcome Measure Information:
Title
3 year overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
3 year disease-free survival
Time Frame
5 year
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events
Time Frame
5 year

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiao Lv
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma

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