Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer

Phase 2

Terminated

• Conditions: Lower Oesophagus Cancer; Stomach Neoplasms; Oesophageal Junction Cancer
• Interventions: Drug: Epirubicin; Drug: Cisplatin; Drug: Paclitaxel; Procedure: gastric surgery

• Registration Number: NCT01830270
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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 taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin 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 (30mg/m2), epirubicin (50 mg/m2) and paclitaxel (90 mg/m2)with 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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Primary Completion: 2015-04
• Status Verified: 2016-01
• Study Completion: 2016-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET regimen	gastric surgery	-
PET regimen	Cisplatin	-
PET regimen	Epirubicin	-
PET regimen	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
curative resection rate	an expected average of 4 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
tolerance of the therapeutic association	1 week after each chemotherapy cycle	Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.
global survival	from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery)
response rate	between 2 and 4 weeks after the end of the last cycle of chemotherapy	Response rate will be evaluated using RECIST v1.1 criteria (Response Evaluation Criteria in Solid Tumors ; Eisenhauer et al, 2009) by a CT-scan done between 2 and 4 weeks after the end of the last cycle to verify the absence of local or distant progression before surgery
histologic response rate	an expected average of 4 weeks after surgery	Histologic response rate will be determined by the pathologist laboratory on operative specimens using Becker's score (Becker et al, 2003) to measure effects of neoadjuvant chemotherapy on gastric cancer.
progression free survival	from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery)

Trial Locations

Locations (3)

Hospital of Belfort-Montbeliard; 🇫🇷 Montbeliard, France

University hospital of Besançon; 🇫🇷 Besançon, France

FNLCC center Georges François Leclerc; 🇫🇷 Dijon, France