IMRT/Pemetrexed/Cisplatin in Esophageal Cancer | NCT01630174

Studies
IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

NCT01630174

Sponsor

Shandong Cancer Hospital and Institute

Status

Unknown status

Last Update Posted

Jun 28, 2012Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Not provided

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 27, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 28, 2012Estimated

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

Jun 27, 2012

Last Update Posted Date

Jun 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect of concomitant late course accelerated hyperfractionation radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent; 2.Acquired pathological diagnosis; 3.Life expectancy≥6 months; 4.Age:18-75 years, male or female; 5.General state of health: ECOG 0-1 grade; 6.Without any chemotherapy or radiotherapy; 7.Subjects meet the following criteria for the clinical laboratory:HG≥100g/L, WBC≥3.5X109 /L, neutrophilic leukocyte≥1.5X109,PLT100X109 /L。CR≤1.5 x N，TB≤2.5XN，AST and ALT≤2.5xN，AKP≤2.5XN.

Exclusion Criteria:

1.Serious infection; 2.Uncontrollable diabetes; 3.Other serious diseases, such as myocardial infarction in 6 months; 4. Participated other clinical trials in 4 weeks or at present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

esophagus cancer patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhongtang Wang, M.D.	Contact	+86.531.67626162		wangzt0528@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Cancer hospital and institute	Recruiting	Jinan	Shandong	250017	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