Multicenter Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital, Lille
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
UNICANCER
Fédération de Recherche en Chirurgie (FRENCH)
Information provided by (Responsible Party):
Christophe MARIETTE, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01717924
First received: October 23, 2012
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma


Condition Intervention Phase
Resectable Signet Ring Cell Gastric Adenocarcinoma
Procedure: peri-operative chemotherapy
Procedure: Surgery first
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Percentage of patients dead in the 2-years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease-free survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • R0 resection rate [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • grade III/IV toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    tolerance will be measured by the rate and grade of chemotherapy's complications

  • post operative morbi-mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Average of patients who benefit from the overall treatment strategy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • emotional status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    It will be assessed by quality of life questionnaire(QLQ-C30, QLQ-STO-22,SF-36) and emotional status questionnaire(CES-D, STAI-Y-A, Brief-IPQ, WCC, ICEC-R, CRA)


Estimated Enrollment: 314
Study Start Date: October 2012
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: peri-operative chemotherapy
Neoadjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5 fluoro-uracil (oral or intra-veinous) Surgery within 3 and 6 weeks after the end of neoadjuvant chemotherapy Adjuvant chemotherapy with 3 cycles of the same chemotherapy within 6 and 12 weeks after surgery
Procedure: peri-operative chemotherapy
Usual treatment strategy for gastric adenocarcinoma
Experimental: surgery first with adjuvant chemotherapy
Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy
Procedure: Surgery first
strategy with a surgical procedure first, without the usual peri-operative chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert classification,histologically proven with the presence of signet ring cells (according to WHO 2000 classification) or diffuse form (according to Lauren classification) on pre-therapeutic biopsies
  • tumoural stage IB, II or III (according to UICC-AJCC 2009)
  • patient judged resectable in a curative intent on inclusion
  • absence of distant metastasis
  • absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy
  • WHO performance status 2 or less
  • age over 18 or under 80 years
  • weight loss at the time of inclusion < 15%
  • neutrophilic polynuclears more than 1500/mm3
  • platelets more than 100000/mm3
  • creatinine clearance more than 50 ml/min
  • serum-albumin more than 30 gram/l
  • bilirubin less than 1,5 normal
  • prothrombin rate over 80%
  • absence of prior treatment with chemotherapy or radiotherapy for gastric cancer
  • absence of kniwn child B or C cirrhosis
  • left ventricular ejection fraction more than 50% before epirubicin treatment
  • extension check-up performed within 4 weeks of inclusion
  • signed written informed consent given by the patient

Exclusion Criteria:

  • no corresponding to the inclusion criteria
  • another malignant tumour treated for curative purposes during the past 5 years excepted basocellular skin carcinoma or in situ uterine cervix cancer
  • allergy to the active substance or one of the excipients in the study drugs
  • pregnancy or breast-feeding
  • any other concommitant treatment, immunotherapy or hormonal therapy
  • history of abdominal or chest radiotherapy
  • any evolving disorder which is not under control (liver failure, kidney failure, respiratory failure, evolving heart failure or myocardial necrosis during the past 6 months)
  • patients who cannot be regularly monitored
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717924

Contacts
Contact: christophe Mariette, MD,PhD +33320444407 christophe.mariette@chru-lille.fr

Locations
France
General and digestive surgical department, Claude Huriez Hospital, University Hospital Recruiting
Lille cedex, France, 59037
Contact: christophe mariette, MD,PhD    +33320444407    christophe.mariette@chru-lille.fr   
Principal Investigator: christophe mariette         
Sponsors and Collaborators
University Hospital, Lille
Federation Francophone de Cancerologie Digestive
UNICANCER
Fédération de Recherche en Chirurgie (FRENCH)
Investigators
Principal Investigator: christophe mariette, MD,PhD FFCD, FNCLCC, FRENCH
  More Information

No publications provided by University Hospital, Lille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe MARIETTE, MD, PhD, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01717924     History of Changes
Other Study ID Numbers: A120566-21
Study First Received: October 23, 2012
Last Updated: August 21, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Lille:
Signet ring cell
gastric adenocarcinoma
peri-operative chemotherapy
surgery

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014