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

NCT ID: NCT01830270

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-07-31

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 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

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.

Conditions

Stomach Neoplasms; Oesophageal Junction Cancer; Lower Oesophagus Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PET regimen

Group Type: EXPERIMENTAL

Epirubicin

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

gastric surgery

Intervention Type: PROCEDURE

surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

gastric surgery

surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.

Intervention Type: PROCEDURE

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital of Besançon

Besançon, , France

FNLCC center Georges François Leclerc

Dijon, , France

Hospital of Belfort-Montbeliard

Montbéliard, , France

Countries

France

References

Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratte S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.

Reference Type: RESULT

PMID: 24824852 (View on PubMed)

Other Identifiers

IPEC-GC

Identifier Type: -

Identifier Source: org_study_id