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

Study Overview
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Brief Summary
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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

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

Conditions
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Signet Ring Cell Gastric Adenocarcinoma

Intervention / Treatment
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* Procedure: peri-operative chemotherapy
* Procedure: Surgery first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peri-operative chemotherapy<br>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<br>* Usual treatment strategy for gastric adenocarcinoma<br>|
| Experimental: surgery first with adjuvant chemotherapy<br>Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy | Procedure: Surgery first<br>* strategy with a surgical procedure first, without the usual peri-operative chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients dead in the 2-years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival at 2 years |  | 2 years | 
| 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 | tolerance will be measured by the rate and grade of chemotherapy's complications | 2 years | 
| post operative morbi-mortality |  | 2 years | 
| Average of patients who benefit from the overall treatment strategy |  | 2 years | 
| quality of life |  | 2 years | 
| emotional status | 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) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy