Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01830270
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2012-03-08
Brief Title:
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Preoperative Chemotherapy With Weekly Cisplatin Epirubicin and Paclitaxel Intensified PET in Patients With Locally Gastric Cancer a Phase II Proof-of-concept Study
Status:
TERMINATED
Status Verified Date:
2016-01
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:
IPEC-GC
Brief Summary:
If surgery remains the main treatment for gastric cancer without distant metastases perioperative-chemotherapy increased the likelihood of progression free survival Perioperative chemotherapy appears to have many advantages to reduce the tumor volume to improve the R0 resection rate and to act on micro-metastases Therefore peri-operative chemotherapy combining cisplatin epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer However several pitfalls remained Particularly only 42 of patients could received post-chemotherapy due to post-operative complications and toxicities To overcome this limitation the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin P epirubicin E and paclitaxel T The increasing evidence of taxanes role in gastric cancer treatment as well as the biological synergisms reported in paclitaxelcisplatin and paclitaxelepirubicin combinations sustain the development of dose density based on PET combination in gastric carcinoma The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen
Detailed Description:
The IPEC-GC study is a proof-of-concept study evaluating the efficacy and feasibility of PET regimen in 61 patients with lower oesophagus oesophagus junction or gastric carcinoma
Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin 30mgm2 epirubicin 50 mgm2 and paclitaxel 90 mgm2with a break of one week without chemotherapy between cycle 4 and 5 Surgery is performed within 4-6 weeks after the end of the last cycle of chemotherapy Primary endpoint of this trial is the curative resection rate R0 R0 must be higher than the 79 achieved in previous published studies Response rate histologic response rate Becker score progression-free survival overall survival impact of complete response in survival and dose-density are secondary endpoints For an ancillary study tumors biopsies and operative specimens and sera will be collected to identify biomarkers correlated with treatment efficacy
This study is carried out by the Besançon University Hospital and were approved by the independent Est-II ethics committee and by the French National Authority for Health AFSSAPS
Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin 30mgm2 epirubicin 50 mgm2 and paclitaxel 90 mgm2with a break of one week without chemotherapy between cycle 4 and 5 Surgery is performed within 4-6 weeks after the end of the last cycle of chemotherapy Primary endpoint of this trial is the curative resection rate R0 R0 must be higher than the 79 achieved in previous published studies Response rate histologic response rate Becker score progression-free survival overall survival impact of complete response in survival and dose-density are secondary endpoints For an ancillary study tumors biopsies and operative specimens and sera will be collected to identify biomarkers correlated with treatment efficacy
This study is carried out by the Besançon University Hospital and were approved by the independent Est-II ethics committee and by the French National Authority for Health AFSSAPS
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