Comparing surgery and chemotherapy for treating a specific type of stomach cancer
Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)
This study is testing whether having surgery first or chemotherapy first is better for people with a specific type of stomach cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Lille) |
| Trial ID | NCT01717924 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of primary surgery versus primary chemotherapy followed by surgery in patients with resectable signet ring cell gastric adenocarcinoma. It is a multicenter, randomized controlled trial designed to determine which approach yields better outcomes for patients. Participants will be assigned to either receive surgery first or undergo chemotherapy before surgery. The study aims to provide insights into the optimal treatment strategy for this rare and aggressive form of gastric cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with resectable signet ring cell gastric adenocarcinoma and no distant metastasis.
Not a fit: Patients with advanced disease, distant metastasis, or those who have previously received chemotherapy or radiotherapy for gastric cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with signet ring cell gastric adenocarcinoma, potentially enhancing survival rates.
How similar studies have performed: Other studies have explored similar treatment approaches in gastric cancer, but this specific comparison of surgery versus chemotherapy in signet ring cell adenocarcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- General and digestive surgical department, Claude Huriez Hospital, University Hospital — Lille, France (Recruiting)
Study contacts
- Principal investigator: Guillaume mariette, MD,PhD — Ffcd, Fnclcc, French
- Study coordinator: Guillaume Piessen, MD,PhD
- Email: guillaume.piessen@chru-lille.fr
- Phone: +33320444407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.