Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01717924
Recruitment Status : Recruiting
First Posted : October 31, 2012
Last Update Posted : June 20, 2018
Federation Francophone de Cancerologie Digestive
Federation of Research in Surgery (FRENCH)
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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 or disease Intervention/treatment Phase
Signet Ring Cell Gastric Adenocarcinoma Procedure: peri-operative chemotherapy Procedure: Surgery first Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : October 2012
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2024

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of patients dead in the 2-years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Disease-free survival at 2 years [ Time Frame: 2 years ]
  2. Disease-free survival at 3 years [ Time Frame: 3 years ]
  3. Overall survival at 3 years [ Time Frame: 3 years ]
  4. R0 resection rate [ Time Frame: within 1 year ]
  5. grade III/IV toxicity [ Time Frame: 2 years ]
    tolerance will be measured by the rate and grade of chemotherapy's complications

  6. post operative morbi-mortality [ Time Frame: 2 years ]
  7. Average of patients who benefit from the overall treatment strategy [ Time Frame: 2 years ]
  8. quality of life [ Time Frame: 2 years ]
  9. emotional status [ Time Frame: 2 years ]
    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)

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01717924

Contact: christophe Mariette, MD,PhD +33320444407

General and digestive surgical department, Claude Huriez Hospital, University Hospital Recruiting
Lille cedex, France, 59037
Contact: christophe mariette, MD,PhD    +33320444407   
Principal Investigator: christophe mariette         
Sponsors and Collaborators
University Hospital, Lille
Federation Francophone de Cancerologie Digestive
Federation of Research in Surgery (FRENCH)
Principal Investigator: christophe mariette, MD,PhD FFCD, FNCLCC, FRENCH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Lille Identifier: NCT01717924     History of Changes
Other Study ID Numbers: 2011_25
2012-000998-24 ( EudraCT Number )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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

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