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

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Epirubicin; Paclitaxel

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.