Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Royal Marsden NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220077
First received: September 19, 2005
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Oesophageal Cancer
Procedure: Endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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

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

Estimated Enrollment: 400
Study Start Date: June 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220077     History of Changes
Other Study ID Numbers: 2110
Study First Received: September 19, 2005
Last Updated: May 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 20, 2014