Status:
TERMINATED
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Stomach Neoplasms
Oesophageal Junction Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 appear...
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 chemo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01830270
Start Date
May 1 2011
End Date
July 1 2016
Last Update
July 26 2018
Active Locations (3)
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1
University hospital of Besançon
Besançon, France, 25000
2
FNLCC center Georges François Leclerc
Dijon, France, 21000
3
Hospital of Belfort-Montbeliard
Montbéliard, France, 25200