Neo-Adjuvant Chemotherapy in Locally Advanced Gastric Cancer
Recruitment status was: Active, not recruiting
|First Received Date ICMJE||December 20, 2006|
|Last Updated Date||December 16, 2008|
|Start Date ICMJE||January 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Rate of complete pathological response|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00414271 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Neo-Adjuvant Chemotherapy in Locally Advanced Gastric Cancer|
|Official Title ICMJE||A Phase II Study of Neo-Adjuvant Chemotherapy in Locally Advanced Gastric Cancer|
Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme inhibited by 5-fluorouracil. TS level in the tumour cells has been reported as predictive to response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. We plan to study TS by IHC in the paraffin blocks of tumour tissue.
A combined comparative genomic hybridization (CGH) and expression microarray analysis of gastric cancer specimens before and after neoadjuvant chemotherapy. CGH will be performed using standard technique routinely done in Dr Patrick Tan's laboratory at the National Cancer Centre, which determines the gain or loss of DNA copies of each chromosome. Total RNA will be extracted from at least one biopsy sample which contains at least 50% cancer cells by homogenization of the tumour tissue and tri-sol method. 5 ug of RNA were amplized and hybridized with the C-DNA microarrays of 18K targets.
1. Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Stage T3-4NxM0 Gastric Cancer|
|Intervention ICMJE||Drug: Capecitabine, doxcetaxol|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination.
Patients must not have received any prior chemotherapy or hormonal therapy for the treatment of gastric cancer.
Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12 weeks.
Adequate organ function including the following:
- Bone marrow: White blood cells (WBC) greater than or equal 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x 109/L Platelets greater than or equal 100 x 109/L Haemoglobin greater than or equal 9g/dL
- Hepatic: Bilirubin within upper limit of normal (ULN), ALT or AST less than or equal 2.5x ULN Alkaline phosphatase less than or equal 2.5x ULN.
- Renal: creatinine less than or equal 1.5x ULN Signed informed consent by patient or legal representative. Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Treatment within the last 30 days with any investigational drug. Concurrent administration of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
Pregnancy. Breast-feeding. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
Poorly controlled diabetes mellitus with fasting blood sugar > 18 mM. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
History of significant neurological or mental disorder, including seizures or dementia.
History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.
History of hypersensitivity to 5-fluorouracil
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Singapore|
|Removed Location Countries|
|NCT Number ICMJE||NCT00414271|
|Other Study ID Numbers ICMJE||JS 0420, 05-09-01-04|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Alex Y. Chang, M.D., Johns Hopkins Singapore International Medical Center|
|Study Sponsor ICMJE||Sidney Kimmel Comprehensive Cancer Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Sidney Kimmel Comprehensive Cancer Center|
|Verification Date||December 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP