Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Epirubicin

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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.

gastric surgery

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

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.

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

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

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

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.

Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for oesophageal junction cancer