Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer
IPEC-GC
Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
1 other identifier
interventional
30
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 26, 2018
January 1, 2016
3.9 years
March 8, 2012
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
curative resection rate
an expected average of 4 weeks after surgery
Secondary Outcomes (5)
response rate
between 2 and 4 weeks after the end of the last cycle of chemotherapy
histologic response rate
an expected average of 4 weeks after surgery
tolerance of the therapeutic association
1 week after each chemotherapy cycle
progression free survival
from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery)
global survival
from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery)
Study Arms (1)
PET regimen
EXPERIMENTALInterventions
8 weekly cycles of chemotherapy with epirubicin (50 mg/m2)associated with cisplatin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
8 weekly cycles of chemotherapy with cisplatin (30 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
8 weekly cycles of chemotherapy with paclitaxel (90 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.
Eligibility Criteria
You may qualify if:
- Age \> 18 and \< 70 years (male and female)
- surgical resectability
- ECOG performance status ≤ 1
- ASA score \< 3 (appreciation by a surgeon)
- BMI \< 30 if an upper oesogastrectomy is required
- no previous cytotoxic chemotherapy
- ejection fraction \> 50% in echocardiography before start of therapy
- written informed consent
- distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
- relapse
- hypersensitivity against Paclitaxel, Epirubicin or Cisplatin
- malignant secondary disease, dated back \< 5 years (exception: in situ carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
- peripheral polyneuropathy
- diabetes complicated by coronary artery disease or vasculopathy
- Severe respiratory insufficiency
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University hospital of Besançon
Besançon, 25000, France
FNLCC center Georges François Leclerc
Dijon, 21000, France
Hospital of Belfort-Montbeliard
Montbéliard, 25200, France
Related Publications (1)
Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratte S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.
PMID: 24824852RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
April 12, 2013
Study Start
May 1, 2011
Primary Completion
April 1, 2015
Study Completion
July 1, 2016
Last Updated
July 26, 2018
Record last verified: 2016-01