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

University Hospital, Lille

Status: Enrolling

Conditions: Signet Ring Cell Gastric Adenocarcinoma

Treatments: Procedure: Surgery first; Procedure: peri-operative chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01717924

2011_25

2012-000998-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 314 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

peri-operative chemotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: peri-operative chemotherapy

surgery first with adjuvant chemotherapy

Experimental group

Description:

Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy

Treatment:

Procedure: Surgery first