Actively Recruiting
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
Led by University Hospital, Lille · Updated on 2026-05-14
314
Participants Needed
1
Research Sites
787 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
F
Federation Francophone de Cancerologie Digestive
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the stomach or oesogastric junction with signet ring cells or diffuse type
- Tumor stage IB, II, or III according to UICC-AJCC 2009
- Tumor judged resectable with curative intent
- No distant metastasis
- No peritoneal carcinomatosis on pre-treatment laparoscopy
- WHO performance status 2 or less
- Age between 18 and 80 years
- Weight loss less than 15% at inclusion
- Neutrophil count more than 1500/mm3
- Platelet count more than 100000/mm3
- Creatinine clearance over 50 ml/min
- Serum albumin over 30 g/l
- Bilirubin less than 1.5 times normal
- Prothrombin rate over 80%
- No prior chemotherapy or radiotherapy for gastric cancer
- No known Child B or C cirrhosis
- Left ventricular ejection fraction over 50% before epirubicin treatment
- Extension check-up performed within 4 weeks before inclusion
- Signed written informed consent
You will not qualify if you...
- Not meeting inclusion criteria
- Another malignant tumor treated curatively in the past 5 years except basal cell skin carcinoma or in situ cervical cancer
- Allergy to study drugs or their excipients
- Pregnancy or breast-feeding
- Any other concomitant treatment, immunotherapy, or hormonal therapy
- History of abdominal or chest radiotherapy
- Any uncontrolled evolving disorder (liver, kidney, respiratory failure, heart failure, or recent myocardial necrosis within 6 months)
- Inability to be regularly monitored
AI-Screening
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Trial Site Locations
Total: 1 location
1
General and digestive surgical department, Claude Huriez Hospital, University Hospital
Lille, France, 59037
Actively Recruiting
Research Team
G
Guillaume Piessen, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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