Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381913
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2011-06-22
Brief Title:
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
Sponsor:
Kagawa University
Organization:
Kagawa University
Study Overview
Official Title:
Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion
Status:
COMPLETED
Status Verified Date:
2005-10
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:
Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis some phase 2 and 3 clinical trials of neoadjuvant chemotherapy NAC are performed in Japan However neoadjuvant chemoradiotherapy NACRT achieves superior local tumor control compared with NAC This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy NACRT in this type of gastric cancer
Detailed Description:
Since S-1 combined drug of tegafur 5-chloro-24-dihydroxypyridine and potassium oxonate was approved in Japan in 1999 after a large-scale clinical trial adjuvant chemotherapy with S-1 has been the standard treatment for stage IIIII gastric cancer However for far-advanced gastric cancer various adjuvant chemotherapies including S-1 have not achieved satisfactory results Therefore Japan Clinical Oncology Group JCOG is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy NAC for locally far-advanced gastric cancer However previous studies of NAC have reported a pathological response rate of 15-50 for the main lesion indicating no significant effect on local tumor control
On the other hand other studies have reported that anticancer drugs including S-1 have a radiosensitizing effect and that neoadjuvant chemoradiotherapy NACRT achieves superior local tumor control compared with NAC Therefore we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion
On the other hand other studies have reported that anticancer drugs including S-1 have a radiosensitizing effect and that neoadjuvant chemoradiotherapy NACRT achieves superior local tumor control compared with NAC Therefore we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None