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

July 24, 2018 updated by: Centre Hospitalier Universitaire de Besançon

Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • University Hospital of Besancon
      • Dijon, France, 21000
        • FNLCC center Georges François Leclerc
      • Montbeliard, France, 25200
        • Hospital of Belfort-Montbeliard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • 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

Non-inclusion criteria :

  • 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
  • patient with weight loss > 10%
  • pregnancy or lactation
  • inclusion in another trial
  • patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET regimen
Drug: Epirubicin
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.
Drug: Cisplatin
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.
Drug: Paclitaxel
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.
Procedure: gastric surgery
surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
curative resection rate
Time Frame: an expected average of 4 weeks after surgery
an expected average of 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 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
between 2 and 4 weeks after the end of the last cycle of chemotherapy
histologic response rate
Time Frame: 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.
an expected average of 4 weeks after surgery
tolerance of the therapeutic association
Time Frame: 1 week after each chemotherapy cycle
Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.
1 week after each chemotherapy cycle
progression free survival
Time Frame: from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery)
from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery)
global survival
Time Frame: from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery)
from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPEC-GC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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