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

Oesophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00220077
• Other study ID #: 2110
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2005
• Last updated: November 23, 2015
• Start date: June 2002

Study information

• Verified date: November 2015
• Source: Royal Marsden NHS Foundation Trust
• Contact: Sheela Rao
• Phone: 0208 642 6011
• Email: sheela.rao[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Second malignancy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer

Intervention

Procedure:
• Endoscopy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.
Secondary	Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.