Clinical trial NCT01717924: Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Signet Ring Cell Gastric Adenocarcinoma
Keywords: Signet ring cell
gastric adenocarcinoma
peri-operative chemotherapy
surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Federation Francophone de Cancerologie Digestive
name: UNICANCER
name: Federation of Research in Surgery (FRENCH)
First posted: 2012-10-31
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of patients dead in the 2-years
timeFrame: 2 years
Secondary outcomes:
measure: Disease-free survival at 2 years
timeFrame: 2 years
measure: Disease-free survival at 3 years
timeFrame: 3 years
measure: Overall survival at 3 years
timeFrame: 3 years
measure: R0 resection rate
timeFrame: within 1 year
measure: grade III/IV toxicity
timeFrame: 2 years
measure: post operative morbi-mortality
timeFrame: 2 years
measure: Average of patients who benefit from the overall treatment strategy
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
measure: emotional status
timeFrame: 2 years
Other outcomes:
Locations:
city: Lille cedex
country: France
facility: General and digestive surgical department, Claude Huriez Hospital, University Hospital
Study officials:
affiliation: FFCD, FNCLCC, FRENCH
name: Guillaume mariette, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.