Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02454647
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2015-05-22
Brief Title:
Induction Chemotherapy Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Induction Chemotherapy Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients Long Term Results From a Single Institution
Status:
COMPLETED
Status Verified Date:
2015-05
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:
The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors
Detailed Description:
Patients with locally advanced gastric cancer T3-4 andor N are included Initially patients are diagnosed by computerized tomography scan and endoscopic ultrasound
The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy Surgery is scheduled 4 to 6 weeks after the end of CRT Pathological response is graded according to the Becker criteria Statistical analysis is performed IBM SPSS v20
Estimate whether R0 resection rate pathological response degree patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size neutrophil lymphocyte ratio NLR and platelet lymphocyte ratio PLR
The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy Surgery is scheduled 4 to 6 weeks after the end of CRT Pathological response is graded according to the Becker criteria Statistical analysis is performed IBM SPSS v20
Estimate whether R0 resection rate pathological response degree patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size neutrophil lymphocyte ratio NLR and platelet lymphocyte ratio PLR
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