Signet Ring Cell Gastric Adenocarcinoma
Conditions
Keywords
Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy, surgery
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
Interventions
PROCEDUREperi-operative chemotherapy
Usual treatment strategy for gastric adenocarcinoma
PROCEDURESurgery first
strategy with a surgical procedure first, without the usual peri-operative chemotherapy
Sponsors
Federation Francophone de Cancerologie Digestive
UNICANCER
Federation of Research in Surgery (FRENCH)
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients dead in the 2-years | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival at 3 years | 3 years | — |
| Overall survival at 3 years | 3 years | — |
| R0 resection rate | within 1 year | — |
| grade III/IV toxicity | 2 years | tolerance will be measured by the rate and grade of chemotherapy's complications |
| Disease-free survival at 2 years | 2 years | — |
| Average of patients who benefit from the overall treatment strategy | 2 years | — |
| quality of life | 2 years | — |
| emotional status | 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) |
| post operative morbi-mortality | 2 years | — |
Countries
France
Contacts
Primary ContactGuillaume Piessen, MD,PhD
Outcome results
None listed