NCT01717924 Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
| NCT ID | NCT01717924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Signet Ring Cell Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 314 participants |
| Start Date | 2012-10 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 314 participants in total. It began in 2012-10 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Guillaume mariette, MD,PhD
PRINCIPAL INVESTIGATOR
FFCD, FNCLCC, FRENCH
Frequently Asked Questions
Who can join the NCT01717924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Signet Ring Cell Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01717924 currently recruiting?
Yes, NCT01717924 is actively recruiting participants. Contact the research team at guillaume.piessen@chru-lille.fr for enrollment information.
Where is the NCT01717924 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT01717924 clinical trial?
NCT01717924 is sponsored by University Hospital, Lille. The principal investigator is Guillaume mariette, MD,PhD at FFCD, FNCLCC, FRENCH. The trial plans to enroll 314 participants.