Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Ly... | NCT02133612

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

NCT02133612

Sponsor

Chinese Academy of Medical Sciences

Status

Completed

Last Update Posted

Apr 14, 2015Estimated

Enrollment

43Actual

Phase

Phase 2

Conditions

Esophageal Cancer

Interventions

paclitaxel; cisplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

May 2012Actual

Completion Date

May 2014Actual

First Submitted Date

May 5, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single arm paclitaxel and cisplatin	Experimental		Drug: paclitaxel; cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paclitaxel; cisplatin	Drug	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.

Measure	Description	Time Frame
3 year overall survival		5 year

Measure	Description	Time Frame
3 year disease-free survival		5 year

Measure	Description	Time Frame
Number of Participants with Adverse Events		5 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jing Huang, M.D	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiao Lv		Beijing	Beijing Municipality	100021	China

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C111043	TP protocol
D017239	Paclitaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided