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

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ClinicalTrials.gov Identifier: NCT01717924
Recruitment Status : Recruiting
First Posted : October 31, 2012
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
UNICANCER
Fédération de Recherche en Chirurgie (FRENCH)
Information provided by (Responsible Party):
University Hospital, Lille

October 23, 2012
October 31, 2012
June 20, 2018
October 2012
April 2021   (Final data collection date for primary outcome measure)
Percentage of patients dead in the 2-years [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01717924 on ClinicalTrials.gov Archive Site
  • Disease-free survival at 2 years [ Time Frame: 2 years ]
  • Disease-free survival at 3 years [ Time Frame: 3 years ]
  • Overall survival at 3 years [ Time Frame: 3 years ]
  • R0 resection rate [ Time Frame: within 1 year ]
  • grade III/IV toxicity [ Time Frame: 2 years ]
    tolerance will be measured by the rate and grade of chemotherapy's complications
  • post operative morbi-mortality [ Time Frame: 2 years ]
  • Average of patients who benefit from the overall treatment strategy [ Time Frame: 2 years ]
  • quality of life [ Time Frame: 2 years ]
  • 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)
  • Disease-free survival at 2 years [ Time Frame: 2 years ]
  • Disease-free survival at 3 years [ Time Frame: 3 years ]
  • Overall survival at 3 years [ Time Frame: 3 years ]
  • R0 resection rate [ Time Frame: within 1 year ]
  • Treatment tolerance [ Time Frame: 2 years ]
    tolerance will be measured by the rate and grade of chemotherapy's complications
  • post operative morbi-mortality [ Time Frame: 2 years ]
  • Average of patients who benefit from the overall treatment strategy [ Time Frame: 2 years ]
  • quality of life [ Time Frame: 2 years ]
  • emotional and cognitive impact of the treatment strategy [ 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)
Not Provided
Not Provided
 
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)
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
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Signet Ring Cell Gastric Adenocarcinoma
  • Procedure: peri-operative chemotherapy
    Usual treatment strategy for gastric adenocarcinoma
  • Procedure: Surgery first
    strategy with a surgical procedure first, without the usual peri-operative chemotherapy
  • 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
    Intervention: Procedure: peri-operative chemotherapy
  • 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
    Intervention: Procedure: Surgery first
Piessen G, Messager M, Le Malicot K, Robb WB, Di Fiore F, Guilbert M, Moreau M, Christophe V, Adenis A, Mariette C. Phase II/III multicentre randomised controlled trial evaluating a strategy of primary surgery and adjuvant chemotherapy versus peri-operative chemotherapy for resectable gastric signet ring cell adenocarcinomas - PRODIGE 19 - FFCD1103 - ADCI002. BMC Cancer. 2013 Jun 10;13:281. doi: 10.1186/1471-2407-13-281.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
314
Same as current
April 2024
April 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: christophe Mariette, MD,PhD +33320444407 christophe.mariette@chru-lille.fr
France
 
 
NCT01717924
2011_25
2012-000998-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
  • Federation Francophone de Cancerologie Digestive
  • UNICANCER
  • Fédération de Recherche en Chirurgie (FRENCH)
Principal Investigator: christophe mariette, MD,PhD FFCD, FNCLCC, FRENCH
University Hospital, Lille
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP