IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630174
Recruitment Status : Unknown
Verified June 2012 by Baosheng Li, Shandong Cancer Hospital and Institute.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Baosheng Li, Shandong Cancer Hospital and Institute

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

Condition or disease
Esophageal Cancer

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2009

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
esophagus cancer patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01630174

Contact: Zhongtang Wang, M.D. +86.531.67626162

China, Shandong
Shandong Cancer hospital and institute Recruiting
Jinan, Shandong, China, 250017
Principal Investigator: Baosheng Li, Ph.D.         
Sub-Investigator: Zhongtang Wang, M.D.         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute

Responsible Party: Baosheng Li, Ph.D., Shandong Cancer Hospital and Institute Identifier: NCT01630174     History of Changes
Other Study ID Numbers: phase 1 pem IMRT
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Baosheng Li, Shandong Cancer Hospital and Institute:
IMRT,Pemetrexed,Cisplatin , Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors