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Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal 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.
ClinicalTrials.gov Identifier: NCT00220077
Recruitment Status : Unknown
Verified November 2015 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove beneficial could be selected. This information will therefore allow chemotherapy to be tailored to the individual tumour. It may help identify those patients with a poorer prognosis who could be selected for further therapy post surgery or a different treatment strategy at the outset.

Condition or disease Intervention/treatment
Oesophageal Cancer Procedure: Endoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer
Study Start Date : June 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.

Secondary Outcome Measures :
  1. Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient with histologically proven operable ,locally advanced and metastatic oesophageal or gastric carcinoma.

Exclusion Criteria:

  • Second malignancy
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00220077


Contacts
Contact: Sheela Rao 0208 642 6011 sheela.rao@rmh.nhs.uk
Contact: Naureen Starling 0208 642 6011 naureen.starling@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Sheela Rao    0208 642 6011    sheela.rao@rmh.nhs.uk   
Contact: Naureen Starling    0208 642 6011    naureen.starling@rmh.nhs   
Principal Investigator: David Cunningham         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220077     History of Changes
Other Study ID Numbers: 2110
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

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