ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 32 for:    "Oncology, Medical"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01830270
Recruitment Status : Terminated
First Posted : April 12, 2013
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Oesophageal Junction Cancer Lower Oesophagus Cancer Drug: Epirubicin Drug: Cisplatin Drug: Paclitaxel Procedure: gastric surgery Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
Study Start Date : May 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: PET regimen Drug: 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.

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.

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.

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




Primary Outcome Measures :
  1. curative resection rate [ Time Frame: an expected average of 4 weeks after surgery ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: between 2 and 4 weeks after the end of the last cycle of chemotherapy ]
    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

  2. histologic response rate [ Time Frame: an expected average of 4 weeks after 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.

  3. tolerance of the therapeutic association [ Time Frame: 1 week after each chemotherapy cycle ]
    Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.

  4. progression free survival [ Time Frame: from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery) ]
  5. global survival [ Time Frame: from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830270


Locations
France
University hospital of Besançon
Besançon, France, 25000
FNLCC center Georges François Leclerc
Dijon, France, 21000
Hospital of Belfort-Montbeliard
Montbeliard, France, 25200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Publications of Results:
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01830270     History of Changes
Other Study ID Numbers: IPEC-GC
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: January 2016

Keywords provided by Centre Hospitalier Universitaire de Besancon:
medical oncology
chemotherapy optimization
dose density

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors