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NCT01630174 Clinical Trial

IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:
Phase I Study of Concurrent Selective Lymph Node Late Course Accelerated Hyper-fractionated Radiotherapy and Pemetrexed, Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01630174
Other study ID # phase 1 pem IMRT
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2012
Last updated June 27, 2012
Start date October 2009

Study information
Verified date June 2012
Source Shandong Cancer Hospital and Institute
Contact Zhongtang Wang, M.D.
Phone +86.531.67626162
Email wangzt0528@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Shandong Cancer hospital and institute Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

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