Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
18 Years
70 Years
Both
Stomach Neoplasms, Oesophageal Junction Cancer, Lower Oesophagus Cancer
Trial Information
Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
curative resection rate
Outcome Time Frame:
an expected average of 4 weeks after surgery
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IPEC-GC
NCT ID:
NCT01830270
Start Date:
May 2011
Completion Date:
May 2019
Related Keywords:
- Stomach Neoplasms
- Oesophageal Junction Cancer
- Lower Oesophagus Cancer
- medical oncology
- chemotherapy optimization
- dose density
- Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Esophageal Neoplasms
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