IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

This study is currently recruiting participants.
Verified June 2012 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Baosheng Li, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01630174
First received: June 27, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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


Condition
Esophageal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Estimated Enrollment: 30
Study Start Date: October 2009
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

esophagus cancer patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630174

Contacts
Contact: Zhongtang Wang, M.D. +86.531.67626162 wangzt0528@163.com

Locations
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
  More Information

No publications provided

Responsible Party: Baosheng Li, Ph.D., Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01630174     History of Changes
Other Study ID Numbers: phase 1 pem IMRT
Study First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014