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IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Shandong Cancer Hospital and Institute.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Shandong
Shandong Cancer hospital and institute
Jinan, Shandong, China, 250017
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
  More Information

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

ClinicalTrials.gov processed this record on December 02, 2016