Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414271
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2006-12-20
Brief Title:
Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Study of Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thymidylate Synthase TS is a key enzyme in the synthesis of DNA and the target enzyme inhibited by 5-fluorouracil 5-FU 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 immunohistochemistry 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 Tans 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 amplified and hybridized with the C-DNA microarrays of 18K targets
Primary Objective 1 Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer
Secondary Objective
1 Complete clinical and pathological response rates to pre-operative chemotherapy in locally advanced gastric cancer
2 Complete resection rate
3 Time to recurrence disease free and overall survival
4 Correlation of clinical outcome with Runt-related transcription factor RUNX-3 methylation status and Thymidylate synthetase in the tumor tissue
5 Correlation of CGH and gene expression profile and their changes after chemotherapy with clinical outcome
Patients may be included in the study only if they meet all of the following criteria
Age at least 18 years Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia Siewert Classification Type III Preoperative Stage T3-4NxM0 by endoscopic ultrasound CT of the abdomenpelvis and laparoscopy CT of the chest if it is a cardia lesion
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 at least 35 x 109L Absolute neutrophil segmented and bands count ANC at least 15 x 109L Platelets at least 100 x 109L Haemoglobin at least 9gdL
- Hepatic Bilirubin within upper limit of normal ULN Aspartate transaminase ALT or Alanine transaminase AST not more than 25x ULN Alkaline phosphatase not more than 25x ULN
- Renal creatinine not more than 15x 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
The study plans to recruit 30 patients in 12-18 months
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 Tans 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 amplified and hybridized with the C-DNA microarrays of 18K targets
Primary Objective 1 Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer
Secondary Objective
1 Complete clinical and pathological response rates to pre-operative chemotherapy in locally advanced gastric cancer
2 Complete resection rate
3 Time to recurrence disease free and overall survival
4 Correlation of clinical outcome with Runt-related transcription factor RUNX-3 methylation status and Thymidylate synthetase in the tumor tissue
5 Correlation of CGH and gene expression profile and their changes after chemotherapy with clinical outcome
Patients may be included in the study only if they meet all of the following criteria
Age at least 18 years Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia Siewert Classification Type III Preoperative Stage T3-4NxM0 by endoscopic ultrasound CT of the abdomenpelvis and laparoscopy CT of the chest if it is a cardia lesion
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 at least 35 x 109L Absolute neutrophil segmented and bands count ANC at least 15 x 109L Platelets at least 100 x 109L Haemoglobin at least 9gdL
- Hepatic Bilirubin within upper limit of normal ULN Aspartate transaminase ALT or Alanine transaminase AST not more than 25x ULN Alkaline phosphatase not more than 25x ULN
- Renal creatinine not more than 15x 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
The study plans to recruit 30 patients in 12-18 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00044000 | OTHER | JHM IRB | None |